HypertensionPhase 3NCT00527514

Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension

A Phase 3 study testing Amlodipine and Olmesartan medoxomil plus amlodipine in people with Hypertension, run by Daiichi Sankyo at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects. 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 plus amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: 18 sitesUnited States
Study dates: Sep 2007to Apr 2008
Phase: Phase 3
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

Males or females greater than or equal to 18 years of age
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mm Hg but less than or equal to 199 mm Hg or a mean seated diastolic blood pressure (MSDBP) greater than or equal to 90 mm Hg and less than or equal to 109 mm Hg, following a period of taking only placebo
Patients with a mean daytime (8AM-4PM) systolic blood pressure greater than or equal to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime diastolic blood pressure less than or equal to 109 mm Hg as measured by an ambulatory blood pressure monitoring device (ABPM), after a period of taking only placebo
If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Who cannot join

History of stroke or transient ischemic attack (TIA) within the last one year
History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll
Patients with hemodynamically significant cardiac valvular disease
Patients with clinically significant cardiac conduction defects, including second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Study site
Beaver, Pennsylvania
Study site
Buena Park, California
Study site
Carrolton, Texas
Study site
Castle Rock, Colorado
Study site
Cincinnati, Ohio
Study site
Corpus Christi, Texas
Study site
Greer, South Carolina
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Natick, Massachusetts
Study site
New York, New York
Study site
Orland Park, Illinois
Study site
Pembroke Pines, Florida
Study site
Sacramento, California
Study site
Tustin, California
Study site
Westlake Village, California
Study site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Prospective, Open-label Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects With Stage 1 and Stage 2 Hypertension

This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.

Conditions: Hypertension
Being tested: Amlodipine, Olmesartan medoxomil plus amlodipine
Keywords: Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Stage I and II Hypertension
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AmlodipineDrug
Tablets
Olmesartan medoxomil plus amlodipineDrug
Tablets

Study groups in NCT00527514
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Amlodipine; Drug: Olmesartan medoxomil plus amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
Measured: Baseline to 12 Weeks

Secondary outcomes (5)

Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
Measured: Baseline to 12 weeks
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Measured: Baseline to end of week 3
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Measured: Baseline to end of week 6
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Measured: Baseline to end of week 9
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group
Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.
Measured: Baseline to end end of week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Apr 2008

First posted11 Sep 2007 (estimated)
Study startSep 2007
Primary completionApr 2008
Study completionApr 2008

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.
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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00527514
Sponsor's protocol ID: 8663-402
Status last verified: Nov 2009
First submitted: 10 Sep 2007
Last updated: 11 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-label Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects With Stage 1 and Stage 2 Hypertension
ClinicalTrials.gov ID: NCT00527514
Acronym / sponsor ID: 8663-402
Conditions: Hypertension
Keywords: Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Stage I and II Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 11 Sep 2007 (estimated)
Results: Posted 23 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Amlodipine, Drug: Olmesartan medoxomil plus amlodipine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males or females greater than or equal to 18 years of age
Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mm Hg but less than or equal to 199 mm Hg or a mean seated diastolic blood pressure (MSDBP) greater than or equal to 90 mm Hg and less than or equal to 109 mm Hg, following a period of taking only placebo
Patients with a mean daytime (8AM-4PM) systolic blood pressure greater than or equal to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime diastolic blood pressure less than or equal to 109 mm Hg as measured by an ambulatory blood pressure monitoring device (ABPM), after a period of taking only placebo
If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Key exclusion criteria (6 listed)

History of stroke or transient ischemic attack (TIA) within the last one year
History of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months
Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll
Patients with hemodynamically significant cardiac valvular disease

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
AmlodipineTablets	Drug	1
Olmesartan medoxomil plus amlodipineTablets	Drug	1

Primary outcome

Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring
Time frame: Baseline to 12 Weeks

5 secondary outcomes

Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure
Time frame: Baseline to 12 weeks
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.
Time frame: Baseline to end of week 3
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.
Time frame: Baseline to end of week 6
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group
Time frame: Baseline to end of week 9
Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group
Time frame: Baseline to end end of week 12

Results and safety

Results posted to the registry on 23 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine and Olmesartan, if Necessary	185	184

Primary outcome: Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring

Time frame: Baseline to 12 Weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Overall Active Treatment Period n = 172
Value	-21.4 (0.80)

Overall Active Treatment Period: p <0.0001, one-sample t-test

Population analysed: The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 week treatment period plus 30 days after the last dose.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Amlodipine 5 mg	0 of 185 (0%)	8 of 185 (4.3%)	Not reported
Amlodipine 5mg and Olmesartan 20 mg	0 of 180 (0%)	23 of 180 (12.8%)	Not reported
Amlodipine 5mg and Olmesartan 40 mg	1 of 161 (0.6%)	11 of 161 (6.8%)	Not reported
Amlodipine 10 mg and Olmesartan 40 mg	1 of 134 (0.7%)	12 of 134 (9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Recruiting
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlodipine and Olmesartan medoxomil plus amlodipine in people with Hypertension, run by Daiichi Sankyo at 18 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 4 inclusion and 6 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 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Sep 2009). 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?

Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring (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 NCT00527514.

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 11 Nov 2009.