Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
NCT ID: NCT00430950
Last Updated: 2019-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1011 participants
INTERVENTIONAL
2007-02-28
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
2
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo
olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
Interventions
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olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
* Patients having a history of the following within the last six months:
* myocardial infarction,
* unstable angina pectoris,
* percutaneous coronary intervention,
* severe heart failure,
* hypertensive encephalopathy, cerebrovascular accident (stroke) or
* transient ischaemic attack.
* Patients with clinically significant abnormal laboratory values at screening.
* Patients with secondary HTN.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Lars Christian Rump, M.D.
Role: STUDY_CHAIR
University of Ruhr-Bochum
Locations
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Bruges, , Belgium
Brussels, , Belgium
Drongen, , Belgium
Godinne, , Belgium
Mouscron, , Belgium
Wetteren, , Belgium
Berlin, , Germany
Dortmund, , Germany
Essen, , Germany
Frankfurt, , Germany
Goch, , Germany
Hamburg, , Germany
Kallstadt, , Germany
Karlsruhe, , Germany
Kassel, , Germany
Magdeburg, , Germany
Marburg, , Germany
München, , Germany
Wiesbaden, , Germany
Wuppertal, , Germany
's-Hertogenbosch, , Netherlands
Alphen aan den Rijn, , Netherlands
Amsterdam-Zuidoost, , Netherlands
Andijk, , Netherlands
De Bilt, , Netherlands
Ewijk, , Netherlands
Heerlen, , Netherlands
Hengelo, , Netherlands
Landgraaf, , Netherlands
Nijmegen, , Netherlands
Oud-Beijerland, , Netherlands
Ridderkerk, , Netherlands
The Hague, , Netherlands
Wildervank, , Netherlands
Zwijndrecht, , Netherlands
Bratislava, , Slovakia
Levice, , Slovakia
Lučenec, , Slovakia
Nitra, , Slovakia
Nové Zámky, , Slovakia
Vráble, , Slovakia
Countries
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References
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Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.
Other Identifiers
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CS866CM-B-E302
Identifier Type: -
Identifier Source: org_study_id
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