- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00890591
Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension (Benibest)
May 27, 2009 updated by: Daiichi Sankyo, Inc.
National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate
In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage 1 and 2 hypertension without treatment for at least 2 weeks
- Women with no risk of becoming pregnant
Exclusion Criteria:
- Study participation could result in risk to health of subject
- Cardiovascular disease
- Secondary hypertension or stage 3 hypertension
- Myocardial infarction within the last 6 months
- Congestive heart failure
- Pulmonary edema
- Valvular alterations or rheumatic cardiopathy
- Clinically relevant conduction disorders significant arrhythmias
- Alcohol or illicit drug use
- Medication abuse
- Pregnant or nursing women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary.
All interventions are once-daily for 4 to 9 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
Time Frame: 4 - 9 wks of olmesartan monotherapy
|
Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg).
If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level
|
4 - 9 wks of olmesartan monotherapy
|
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)
Time Frame: 4 to 9 weeks on combination therapy
|
Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks
|
4 to 9 weeks on combination therapy
|
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)
Time Frame: 4 to 9 weeks
|
Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide).
If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.
|
4 to 9 weeks
|
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)
Time Frame: 4 - 9 weeks
|
Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg).
This combination was maintained as long as the participant's blood pressure remained within predefined parameters.
If not, participant discontinued for lack of efficacy.
|
4 - 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
February 11, 2009
First Submitted That Met QC Criteria
March 20, 2009
First Posted (Estimate)
April 30, 2009
Study Record Updates
Last Update Posted (Estimate)
June 3, 2009
Last Update Submitted That Met QC Criteria
May 27, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Amlodipine
- Olmesartan
- Olmesartan Medoxomil
- Hydrochlorothiazide
Other Study ID Numbers
- SPB-OM-0106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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