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Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430950
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : April 20, 2009
Last Update Posted : January 10, 2019
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1011 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

    Change in mean trough sitting diastolic Blood Pressure 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.

    Change = Week 16 - Week 8 (baseline).

Secondary Outcome Measures :
  1. Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 [ Time Frame: 4 weeks ]
    Change = Week 12 - Week 8 (baseline).

  2. Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. [ Time Frame: 8 weeks ]
    4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).

  3. Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. [ Time Frame: 8 weeks ]
    Change = Week 16 - Week 8 (baseline).

  4. Number of Participants Achieving Blood Pressure Goal. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430950

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Brugge, Belgium
Brussels, Belgium
Drongen, Belgium
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 den Rijn, Netherlands
Amsterdam Zuidoost, Netherlands
Andijk, Netherlands
De Bilt, Netherlands
Den Bosch, Netherlands
Den Haag, Netherlands
Ewijk, Netherlands
Heerlen, Netherlands
Hengelo, Netherlands
Landgraaf, 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, a Daiichi Sankyo Company
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Study Chair: Professor Lars Christian Rump, M.D. University of Ruhr-Bochum
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00430950    
Other Study ID Numbers: CS866CM-B-E302
First Posted: February 2, 2007    Key Record Dates
Results First Posted: April 20, 2009
Last Update Posted: January 10, 2019
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address:
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Keywords provided by Daiichi Sankyo, Inc.:
Moderate-to-Severe Hypertension
Essential Hypertension
Combination Therapy
Fixed-Combination Dose
Additional relevant MeSH terms:
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Olmesartan Medoxomil
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
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