Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Daiichi Sankyo Inc. Daiichi Sankyo Europe, GmbH |
---|---|
Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00430950 |
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
Condition | Intervention | Phase |
---|---|---|
Essential Hypertension |
Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy |
Enrollment: | 1011 |
Study Start Date: | February 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
|
Drug: 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: Experimental
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo
|
Drug: 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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients having a history of the following within the last six months:
Belgium | |
Wetteren, Belgium | |
Brugge, Belgium | |
Mouscron, Belgium | |
Drongen, Belgium | |
Brussels, Belgium | |
Mont-Godinne, Belgium | |
Germany | |
Karlsruhe, Germany | |
Marburg, Germany | |
Kassel, Germany | |
Goch, Germany | |
Berlin, Germany | |
Muenchen, Germany | |
Magdeburg, Germany | |
Frankfurt, Germany | |
Dortmund, Germany | |
Wuppertal, Germany | |
Hamburg, Germany | |
Wiesbaden, Germany | |
Essen, Germany | |
Kallstadt, Germany | |
Netherlands | |
Ewijk, Netherlands | |
Wildervank, Netherlands | |
Hengelo, Netherlands | |
Heerlen, Netherlands | |
Landgraaf, Netherlands | |
Nijmegen, Netherlands | |
Andijk, Netherlands | |
Zwijndrecht, Netherlands | |
Alphen aan de Rijn, Netherlands | |
De Bilt, Netherlands | |
Amsterdam Zuidoost, Netherlands | |
Den Bosch, Netherlands | |
Oud-Beijerland, Netherlands | |
Den Haag, Netherlands | |
Ridderkerk, Netherlands | |
Levice, Netherlands | |
Slovakia | |
Levice, Slovakia | |
Nitra, Slovakia | |
Nove Zamky, Slovakia | |
Vrable, Slovakia | |
Lucenec, Slovakia | |
Bratislava, Slovakia |
Study Chair: | Professor Lars Christian Rump, M.D. | University of Ruhr-Bochum |
Responsible Party: | Daichi Sankyo Europe, GmbH ( Dr. Bettina Ammentorp ) |
Study ID Numbers: | CS866CM-B-E302 |
Study First Received: | February 1, 2007 |
Results First Received: | February 9, 2009 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00430950 History of Changes |
Health Authority: | EU: EMEA; Germany: Bundesministerium fur Gesundeheit und Soziale Sicherung; The Netherlands: Staatstoezicht op de volksgezondheid; Ukraine: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Belgium: Directorate general for the protection of Public health: Medicines; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Moderate-to-Severe Hypertension Essential Hypertension Combination Therapy Fixed-Combination Dose |
Angiotensin II Type 1 Receptor Blockers Essential Hypertension Sodium Chloride Symporter Inhibitors Diuretics Vascular Diseases Olmesartan medoxomil |
Cardiovascular Agents Angiotensin II Antihypertensive Agents Hydrochlorothiazide Hypertension |
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Olmesartan medoxomil Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |