Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets (Drug); olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daiichi Sankyo Inc. Official(s) and/or principal investigator(s): Professor Lars Christian Rump, M.D., Study Chair, Affiliation: University of Ruhr-Bochum
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Mean Trough Sitting Diastolic Blood Pressure
Secondary outcome: Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. Change in Daytime, Nighttime and 24-Hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. Number of Participants Achieving Blood Pressure Goal.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female Europeans aged 18 years or older with moderate to severe HTN, defined
as follows (conventional BP measurements)
Exclusion Criteria:
- Female patients of childbearing potential pregnant, lactating or planning to become
pregnant during the trial period.
- 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.
Locations and Contacts
Brugge, Belgium
Brussels, Belgium
Drongen, Belgium
Mont-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
Muenchen, Germany
Wiesbaden, Germany
Wuppertal, Germany
Alphen aan de Rijn, Netherlands
Amsterdam Zuidoost, Netherlands
Andijk, Netherlands
De Bilt, Netherlands
Den Bosch, Netherlands
Den Haag, Netherlands
Ewijk, Netherlands
Heerlen, Netherlands
Hengelo, Netherlands
Landgraaf, Netherlands
Levice, Netherlands
Nijmegen, Netherlands
Oud-Beijerland, Netherlands
Ridderkerk, Netherlands
Wildervank, Netherlands
Zwijndrecht, Netherlands
Bratislava, Slovakia
Levice, Slovakia
Lucenec, Slovakia
Nitra, Slovakia
Nove Zamky, Slovakia
Vrable, Slovakia
Additional Information
Starting date: February 2007
Last updated: April 29, 2009
|