HypertensionPhase 4BP CRUSHNCT00791258
A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
A Phase 4 study testing amlodipine and olmesartan medoxomil tablets and hydrochlorothiazide tablets in people with Hypertension, run by Daiichi Sankyo at 72 sites in United States.
Trial summary
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- amlodipine and olmesartan medoxomil tablets and hydrochlorothiazide tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 999 participants
- Where
- 72 sitesUnited States
- Study dates
- Nov 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= to 18 years of age
- Hypertension uncontrolled on current monotherapy
- Females:
- negative serum pregnancy test at screening
- post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control
Who cannot join
- Pregnant females
- Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
- Diabetes requiring insulin
- Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
- History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
- History of Class III or IV congestive heart failure
- History of stroke or transient ischemic attack within the last 1 year
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
United States72 sites
Study site
Addison, Illinois
Study site
Albuquerque, New Mexico
Study site
Amarillo, Texas
Study site
Anaheim, California
Study site
Austin, Texas
Study site
Binghamton, New York
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Boynton Beach, Florida
Study site
Brooksville, Florida
Study site
Carrollton, Texas
Study site
Cary, North Carolina
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Columbia, Maryland
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Deerfield Beach, Florida
Study site
DeLand, Florida
Study site
Edison, New Jersey
Study site
Elkridge, Maryland
Study site
Eugene, Oregon
Study site
Fort Lauderdale, Florida
Study site
Green Valley, Arizona
Study site
Greenville, South Carolina
Study site
Harbor City, California
Study site
Harrisburg, North Carolina
Study site
Havertown, Pennsylvania
Study site
Hickory, North Carolina
Study site
High Point, North Carolina
Study site
Jenkintown, Pennsylvania
Study site
Kissimmee, Florida
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Longview, Texas
Study site
Madison, Wisconsin
Study site
Mesa, Arizona
Study site
Milford, Connecticut
Study site
Mt. Pleasant, South Carolina
Study site
National City, California
Study site
New Tazewell, Tennessee
Study site
Norfolk, Virginia
Study site
Norman, Oklahoma
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Orland Park, Illinois
Study site
Oxon Hill, Maryland
Study site
Pembroke Pines, Florida
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Pueblo, Colorado
Study site
Raleigh, North Carolina
Study site
Reisterstown, Maryland
Study site
Sarasota, Florida
Study site
Sewell, New Jersey
Study site
Sierra Vista, Arizona
Study site
St. Petersburg, Florida
Study site
Stevensville, Michigan
Study site
Tampa, Florida
Study site
Tempe, Arizona
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Tustin, California
Study site
Walla Walla, Washington
Study site
West Jordan, Utah
Study site
Westlake Village, California
Study site
Wichita, Kansas
Study site
Wilmington, North Carolina
Study site
Winston-Salem, North Carolina
About this study
Official title: A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.
- Conditions
- Hypertension
- Being tested
- amlodipine and olmesartan medoxomil tablets, hydrochlorothiazide tablets
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine and olmesartan medoxomil tabletsDrug
Also called AZOR Tablets
amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
hydrochlorothiazide tabletsDrug
hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks Receives: Drug: amlodipine and olmesartan medoxomil tablets; Drug: hydrochlorothiazide tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks
Measured: baseline to 12 weeks
Secondary outcomes (58)
The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks
Measured: baseline to 12 weeks
The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks
Measured: Baseline to 12 and 20 weeks
Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.
Measured: Baseline to 12 weeks
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.
Measured: Baseline to 20 weeks
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.
Measured: Baseline to 12 weeks
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.
Measured: Baseline to 20 weeks
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.
Measured: Baseline to 12 weeks
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.
Measured: Baseline to 20 weeks
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.
Measured: Baseline to 12 weeks
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values
Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.
Measured: Baseline to 20 weeks
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Measured: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Measured: Baseline to 12 weeks
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Measured: Baseline to 20 weeks
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Measured: Baseline to 12 weeks
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Measured: Baseline to 20 weeks
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Measured: Baseline to 12 weeks
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Measured: Baseline to 20 weeks
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Measured: Baseline to 12 weeks
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Measured: Baseline to 20 weeks
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Measured: Baseline to 12 weeks
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Measured: Baseline to 20 weeks
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Measured: Baseline to 12 weeks
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Measured: Baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791258
- Sponsor's protocol ID
- CS8663-404
- Acronym
- BP CRUSH
- Status last verified
- Sep 2010
- First submitted
- 13 Nov 2008
- Last updated
- 9 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Nesbitt SD, Shojaee A, Maa JF, Weir MR. Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study). J Hum Hypertens. 2013 Jul;27(7):445-52. doi: 10.1038/jhh.2012.65. Epub 2012 Dec 20.
PubMed 23254596Hsueh WA, Shojaee A, Maa JF, Neutel JM. Efficacy of amlodipine/olmesartan medoxomil +/- HCTZ in obese patients uncontrolled on antihypertensive monotherapy. Curr Med Res Opin. 2012 Nov;28(11):1809-18. doi: 10.1185/03007995.2012.740632. Epub 2012 Oct 30.
PubMed 23072496
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy
- ClinicalTrials.gov ID
- NCT00791258
- Acronym / sponsor ID
- BP CRUSH / CS8663-404
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 29 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: amlodipine and olmesartan medoxomil tablets, Drug: hydrochlorothiazide tabletsAzor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= to 18 years of age
- Hypertension uncontrolled on current monotherapy
- Females:
- negative serum pregnancy test at screening
- post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control
Key exclusion criteria (7 listed)
- Pregnant females
- Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
- Diabetes requiring insulin
- Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
- History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amlodipine and olmesartan medoxomil tabletsAlso: AZOR Tabletsamlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks | Drug | 1 |
| hydrochlorothiazide tabletshydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks | Drug | 1 |
Primary outcome
The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks
Time frame: baseline to 12 weeks
58 secondary outcomes
The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks
Time frame: baseline to 12 weeks
The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks
Time frame: Baseline to 12 and 20 weeks
Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Time frame: Baseline to 20 weeks
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Time frame: Baseline to 20 weeks
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Time frame: Baseline to 12 weeks
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Time frame: Baseline to 20 weeks
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values
Time frame: Baseline to 12 weeks
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values
Time frame: Baseline to 20 weeks
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time frame: Baseline to 4, 8, 12, 16, 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23254596Nesbitt SD, Shojaee A, Maa JF, Weir MR. Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study). J Hum Hypertens. 2013 Jul;27(7):445-52. doi: 10.1038/jhh.2012.65. Epub 2012 Dec 20.
- Derived from this study: PubMed 23072496Hsueh WA, Shojaee A, Maa JF, Neutel JM. Efficacy of amlodipine/olmesartan medoxomil +/- HCTZ in obese patients uncontrolled on antihypertensive monotherapy. Curr Med Res Opin. 2012 Nov;28(11):1809-18. doi: 10.1185/03007995.2012.740632. Epub 2012 Oct 30.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amlodipine and olmesartan medoxomil tablets and hydrochlorothiazide tablets in people with Hypertension, run by Daiichi Sankyo at 72 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00791258, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.