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Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

This study has been completed.
Daiichi Sankyo Europe, GmbH
Information provided by:
Daiichi Sankyo, Inc. Identifier:
First received: February 1, 2007
Last updated: April 29, 2009
Last verified: April 2009
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Change in Mean Trough Sitting Diastolic Blood Pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 [ Time Frame: 4 weeks ]
  • Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. [ Time Frame: 8 weeks ]
  • Change in Daytime, Nighttime and 24-Hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. [ Time Frame: 8 weeks ]
  • Number of Participants Achieving Blood Pressure Goal. [ Time Frame: 8 weeks ]

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
Experimental: 1
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
Experimental: 2
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00430950

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
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Europe, GmbH
Study Chair: Professor Lars Christian Rump, M.D. University of Ruhr-Bochum
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Bettina Ammentorp, Daichi Sankyo Europe, GmbH Identifier: NCT00430950     History of Changes
Other Study ID Numbers: CS866CM-B-E302
Study First Received: February 1, 2007
Results First Received: February 9, 2009
Last Updated: April 29, 2009

Keywords provided by Daiichi Sankyo, Inc.:
Moderate-to-Severe Hypertension
Essential Hypertension
Combination Therapy
Fixed-Combination Dose

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Olmesartan Medoxomil
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on September 21, 2017