Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: olmesartan medoxomil (Drug); olmesartan medoxomil + hydrochlorothiazide (Drug); olmesartan medoxomil + hydrochlorothiazide tablets (Drug); olmesarsan medoxomil (Other)
Phase: Phase 3
Status: Recruiting
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
Overall contact:
Dr. Lars Christian Rump, MD; PhD, Phone: 0049 2323 499 1670, Email: Christian.Rump@ruhr-uni-bochum.de
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: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the efficacy in lowering mean trough sitting dBP between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.
Secondary outcome: Reduction in sitting systolic blood pressure.Reduction in daytime, nighttime and 24-hr blood pressure evaluated by ABPM. Percentage of patients achieving BP goal. Safety and tolerability.
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
Dr. Lars Christian Rump, MD; PhD, Phone: 0049 2323 499 1670, Email: Christian.Rump@ruhr-uni-bochum.de
Wetteren, Belgium; Recruiting
Brugge, Belgium; Recruiting
Mouscron, Belgium; Recruiting
Drongen, Belgium; Recruiting
Brussels, Belgium; Recruiting
Mont-Godinne, Belgium; Recruiting
Karlsruhe, Germany; Recruiting
Marburg, Germany; Recruiting
Kassel, Germany; Recruiting
Goch, Germany; Recruiting
Berlin, Germany; Recruiting
Muenchen, Germany; Recruiting
Magdeburg, Germany; Recruiting
Franfurt, Germany; Recruiting
Dortmund, Germany; Recruiting
Wuppertal, Germany; Recruiting
Hamburg, Germany; Recruiting
Wiesbaden, Germany; Recruiting
Essen, Germany; Recruiting
Kallstadt, Germany; Recruiting
Ewijk, Netherlands; Recruiting
Wildervank, Netherlands; Recruiting
Hengelo, Netherlands; Recruiting
Heerlen, Netherlands; Recruiting
Landgraaf, Netherlands; Recruiting
Nijmegen, Netherlands; Recruiting
Andijk, Netherlands; Recruiting
Den Bosch, Netherlands; Recruiting
Alphen aan de Rijn, Netherlands; Recruiting
De Bilt, Netherlands; Recruiting
Amsterdam Zuidoost, Netherlands; Recruiting
Zwijndrecht, Netherlands; Recruiting
Oud-Beijerland, Netherlands; Recruiting
Den Haag, Netherlands; Recruiting
Ridderkerk, Netherlands; Recruiting
Levice, Netherlands; Recruiting
Levice, Slovakia; Recruiting
Bratislava, Slovakia; Recruiting
Nove Zamky, Slovakia; Recruiting
Vrable, Slovakia; Recruiting
Lucenec, Slovakia; Recruiting
Nitra, Slovakia; Recruiting
Additional Information
Starting date: February 2007
Ending date: June 2008
Last updated: January 8, 2008
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