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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


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 12

Change 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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