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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | 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 medoximil Drug: amlodipine besylate Drug: hydrochlorothiazide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 2320 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5mg: Experimental
olmesartan meodoximil 20mg / amlodipine besylate 5 mg / hydrochlorothiazide 12.5mg
|
Drug: olmesartan medoximil
olmesartan medoximil 20 mg
Drug: amlodipine besylate
amlodipine besylate 5 mg
Drug: hydrochlorothiazide
hydrochlorothiazide 12.5mg
|
| olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5mg: Experimental |
Drug: olmesartan medoximil
olmesartan medoximil 40 mg
Drug: amlodipine besylate
amlodipine besylate 5 mg
Drug: hydrochlorothiazide
hydrochlorothiazide 12.5mg
|
| olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/25mg: Experimental |
Drug: olmesartan medoximil
olmesartan medoximil 40 mg
Drug: amlodipine besylate
amlodipine besylate 5 mg
Drug: hydrochlorothiazide
hydrochlorothiazide 25mg
|
| olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/12.5mg: Experimental |
Drug: olmesartan medoximil
olmesartan medoximil 40 mg
Drug: amlodipine besylate
amlodipine besylate 10 mg
Drug: hydrochlorothiazide
hydrochlorothiazide 12.5mg
|
| olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/25mg: Experimental |
Drug: olmesartan medoximil
olmesartan medoximil 40 mg
Drug: amlodipine besylate
amlodipine besylate 10 mg
Drug: hydrochlorothiazide
hydrochlorothiazide 25mg
|
|
olmesartan/amlodipine 20mg/5mg: Experimental
olmesartan medoximil 20mg / amlodipine besylate 5mg
|
Drug: olmesartan medoximil
olmesartan medoximil 20 mg
Drug: amlodipine besylate
amlodipine besylate 5 mg
|
| olmesartan/amlodipine 40mg/5mg: Experimental |
Drug: olmesartan medoximil
olmesartan medoximil 40 mg
Drug: amlodipine besylate
amlodipine besylate 5 mg
|
| olmesartan/amlodipine 40mg/10mg: Experimental |
Drug: olmesartan medoximil
olmesartan medoximil 40 mg
Drug: amlodipine besylate
amlodipine besylate 10 mg
|
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 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| Contact: Esther Janssen | +33(0)146902451 | esther.janssen@mdsinc.com |
| Contact: Carole Cohen | carole.cohen@mdsinc.com |
Show 133 Study Locations
More Information
| Responsible Party: | Daiichi Sankyo Europe ( Director Scientific & Medical Affairs ) |
| Study ID Numbers: | CS8635-A-E302 |
| Study First Received: | June 16, 2009 |
| Last Updated: | January 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00923091 History of Changes |
| Health Authority: | Latvia: State Agency of Medicines |
|
triple combination parallel group dual combination |
|
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 |