HypertensionPhase 4NCT00185120
Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker
A Phase 4 study testing Olmesartan medoxomil, Hydroclorothiazide and Benazepril in people with Hypertension, run by Daiichi Sankyo at 20 sites in United States.
Trial summary
A comparison of 2 different combinations of high blood pressure medications to treat hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Olmesartan medoxomil, Hydroclorothiazide and Benazepril
- How many people
- 152 participants
- Where
- 20 sitesUnited States
- Study dates
- Sep 2005to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Greater than 18 years of age
- Patients with high blood pressure
Who cannot join
- Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months
- History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
- Type 1 diabetes mellitus
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Androscoggin Cardiology Research
Auburn, Maine, 04210
Punzi Medical Center
Carrollton, Texas, 75006
Internal Medicine Associates of Charlotte
Charlotte, North Carolina, 28211
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45319
Clinical Research of South Florida
Coral Gables, Florida, 33134
The Greater Fort Lauderdale Heart Group Research
Fort Lauderdale, Florida, 33308
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Volunteer Research Group, University of Tennessee Med. Ctr.
Knoxville, Tennessee, 37920
Memorial Research Medical Center
Long Beach, California, 90806
National Research Institute
Los Angeles, California, 90057
SFBC International
Miami, Florida, 33142
Study site
Mobile, Alabama, 36693
Clinical Trials Research
Roseville, California, 95661
Apex Research Institute
Santa Ana, California, 92705
CLIRECO, Inc.
Tamarac, Florida, 33321
Orange County Research Center
Tustin, California, 92780
Omega Medical Research
Warwick, Rhode Island, 02886
Westlake Medical Center
Westlake Village, California, 91361
Heartland Research Associates
Wichita, Kansas, 67207
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Study on the Efficacy and Safety of Olmesartan Medoxomil and Its Combination With Hydrochlorothiazide Compared With an ACE Inhibitor and Its Combination With a Calcium Channel Blocker in Patients With Stage 2 Hypertension
A comparison of 2 different combinations of high blood pressure medications to treat hypertension
- Conditions
- Hypertension
- Being tested
- Olmesartan medoxomil, Hydroclorothiazide, Benazepril, Amlodipine
- Keywords
- Hypertension, angiotensin receptor blocker, calcium channel blocker, angiotensin converting enzyme inhibitor hydroclorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
HydroclorothiazideDrug
BenazeprilDrug
AmlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure from the start of the study
Secondary outcomes (2)
Change in diastolic blood pressure from the start of the study
Percent of patients who achieve target blood pressure goals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 152 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185120
- Sponsor's protocol ID
- 866-447
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2005
- Last updated
- 18 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Olmesartan Medoxomil and Its Combination With Hydrochlorothiazide Compared With an ACE Inhibitor and Its Combination With a Calcium Channel Blocker in Patients With Stage 2 Hypertension
- ClinicalTrials.gov ID
- NCT00185120
- Acronym / sponsor ID
- 866-447
- Conditions
- Hypertension
- Keywords
- Hypertension, angiotensin receptor blocker, calcium channel blocker, angiotensin converting enzyme inhibitor hydroclorothiazide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison of 2 different combinations of high blood pressure medications to treat hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Greater than 18 years of age
- Patients with high blood pressure
Key exclusion criteria (3 listed)
- Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months
- History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
- Type 1 diabetes mellitus
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 |
|---|---|---|
| Olmesartan medoxomil | Drug | – |
| Hydroclorothiazide | Drug | – |
| Benazepril | Drug | – |
| Amlodipine | Drug | – |
Primary outcome
Change in systolic blood pressure from the start of the study
2 secondary outcomes
Change in diastolic blood pressure from the start of the study
Percent of patients who achieve target blood pressure goals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
20 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 Olmesartan medoxomil, Hydroclorothiazide and Benazepril in people with Hypertension, run by Daiichi Sankyo at 20 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 2 inclusion and 3 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 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in systolic blood pressure from the start of the study. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2012.