Tracking Information
Start Date ICMJE | June 2009 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: June 16, 2009) | change in seated diastolic blood pressure (SeDBP). change = end week 10 - beginning week 3. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00923091 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: June 16, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Parallel-Group Comparison of Olmesartan, Amlodipine and Hydrochlorothiazide in Hypertension |
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Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Essential Hypertension |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 2320 | ||||||||
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Estimated Completion Date | April 2011 | ||||||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | 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:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Belgium, Bulgaria, Czech Republic, Denmark, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Romania, Russian Federation, Slovakia, Spain, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00923091 |
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Responsible Party | Director Scientific & Medical Affairs, Daiichi Sankyo Europe |
Study ID Numbers ICMJE | CS8635-A-E302 |
Study Sponsor ICMJE | Daiichi Sankyo Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Daiichi Sankyo Inc. |