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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00649389 |
Purpose
To determine the effectiveness of three anti-hypertension approved therapies for lowering blood pressure
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Drug: Olmesartan medoxomil/Amlodipine besylate Drug: Olmesartan medoxomil/Hydrochlorothiazide Drug: Amlodipine/Hydrochlorothiazide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-Administration of a Triple Combination Therapy of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide in Subjects With Hypertension |
| Enrollment: | 2500 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide
recommended dosages, 1 year
|
| 2: Active Comparator |
Drug: Olmesartan medoxomil/Amlodipine besylate
recommended dosages, 1 year.
|
| 3: Active Comparator |
Drug: Olmesartan medoxomil/Hydrochlorothiazide
recommended dosages, 1 year.
|
| 4: Active Comparator |
Drug: Amlodipine/Hydrochlorothiazide
recommended dosages, 1 year.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female newly diagnosed hypertensive subjects or currently on hypertension medication.
Will practice birth control throughout the study by the following: oral or patch contraceptive, injectable or implantable contraceptive medication, intrauterine device, diaphragm or female condom plus spermicide
Exclusion Criteria:
Contacts and Locations
Show 236 Study Locations
More Information
| Responsible Party: | Daiichi Sankyo Inc. ( Executive Director Clinical Development ) |
| Study ID Numbers: | CS8635-A-U301 |
| Study First Received: | March 28, 2008 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00649389 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Calcium Channel Blockers Olmesartan medoxomil Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Pharmacologic Actions Amlodipine Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |