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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by (Responsible Party): | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00923091 |
Purpose
This study is to determine the change in blood pressure from the administration of Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations with Olmesartan/Amlodipine.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo Drug: Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide Drug: olmesartan medoxomil + amlodipine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomised, Double-Blind, Parallel-Group Study Evaluating Efficacy and Safety of Co-Administration of Triple Combinations of Olmesartan Medoxomil, Amlodipine Besylate, and Hydrochlorothiazide Compared With Corresponding Olmesartan - Amlodipine Combination in Subjects With Hypertension |
| Enrollment: | 2689 |
| Study Start Date: | June 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5mg
olmesartan medoxomil 20mg / amlodipine besylate 5 mg / hydrochlorothiazide 12.5mg
|
Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo
One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
Other Name: Azor
|
| Experimental: olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5mg |
Drug: Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo
One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
Other Name: Azor
|
| Experimental: olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/25mg |
Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide
One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
Other Names:
|
| Experimental: olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/12.5mg |
Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide
One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
Other Name: Azor
|
| Experimental: olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/25mg |
Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide
One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
Other Name: Azor
|
|
Experimental: olmesartan/amlodipine 20mg/5mg
olmesartan medoxomil 20mg / amlodipine besylate 5mg
|
Drug: olmesartan medoxomil + amlodipine
One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day
Other Name: Azor
|
| Experimental: olmesartan/amlodipine 40mg/5mg |
Drug: olmesartan medoxomil + amlodipine
One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day.
|
| Experimental: olmesartan/amlodipine 40mg/10mg |
Drug: olmesartan medoxomil + amlodipine
One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day.
Other Name: Azor
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The difference in mean SeSBP/SeDBP between the visit prior to randomisation and the randomisation visit must be ≤ 20/10 mmHg. Subjects not currently on antihypertensive (HTN) medication may meet this requirement at the screening visit (Visit 1) and the randomization visit (Visit 3). Subjects washing out of HTN medication must meet this requirement at least by Visit 2 (or Visit 2.1, if needed) and Visit 3. All subjects undergoing washout of their prior antihypertensive medication will have the opportunity to re-visit the study sites for additional visits during washout (Visits 2 and 2.1) to assess eligibility for randomisation.
Exclusion Criteria:
Subjects with clinically significant abnormal laboratory values at Screening, including subjects with one or more of the following:
Contacts and Locations
Show 133 Study Locations
More Information
| Responsible Party: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00923091 History of Changes |
| Other Study ID Numbers: | CS8635-A-E302 |
| Study First Received: | June 16, 2009 |
| Results First Received: | January 30, 2012 |
| Last Updated: | April 6, 2012 |
| Health Authority: | Latvia: State Agency of Medicines |
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triple combination parallel group dual combination |
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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 |