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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00649389 |
Purpose
To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Olmesartan medoxomil Drug: Amlodipine Drug: Hydrochlorothiazide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: OM40/AML10
olmesartan medoxomil 40mg and amlodipine 10mg
|
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar
Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc
|
|
Active Comparator: OM40/HCTZ25
olmesartan medoxomil 40mg and hydrochlorothiazide 25mg
|
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg
|
|
Active Comparator: AML10/HCTZ25
amlodipine 10mg and hydrochlorothiazide 25mg
|
Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg
|
|
Active Comparator: OM40/AML10/HCTZ25
olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg
|
Drug: Olmesartan medoxomil
40mg olmesartan medoxomil
Other Name: Benicar
Drug: Amlodipine
Amlodipine 10mg
Other Name: Norvasc
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25mg
|
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 234 Study Locations
More Information
| Responsible Party: | Executive Director Clinical Development, Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00649389 History of Changes |
| Other Study ID Numbers: | CS8635-A-U301 |
| Study First Received: | March 28, 2008 |
| Results First Received: | August 9, 2010 |
| Last Updated: | August 31, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Olmesartan medoxomil Amlodipine Olmesartan Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Calcium Channel Blockers Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |