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Trial record 45 of 427 for:    Hydrochlorothiazide

Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00430950
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : April 20, 2009
Last Update Posted : October 12, 2017
Daiichi Sankyo Europe, GmbH
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

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
Primary Completion Date : May 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 ]

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00430950

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
Study Chair: Professor Lars Christian Rump, M.D. University of Ruhr-Bochum

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00430950     History of Changes
Other Study ID Numbers: CS866CM-B-E302
First Posted: February 2, 2007    Key Record Dates
Results First Posted: April 20, 2009
Last Update Posted: October 12, 2017
Last Verified: October 2017

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