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Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430950
First Posted: February 2, 2007
Last Update Posted: October 12, 2017
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.
Collaborator:
Daiichi Sankyo Europe, GmbH
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
  Purpose
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 ]

    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:
  • 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).

  • 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).

  • 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).

  • 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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


Locations
Belgium
Brugge, Belgium
Brussels, Belgium
Drongen, Belgium
Godinne, Belgium
Mouscron, Belgium
Wetteren, Belgium
Germany
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
Netherlands
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
Slovakia
Bratislava, Slovakia
Levice, Slovakia
Lucenec, Slovakia
Nitra, Slovakia
Nove Zamky, Slovakia
Vrable, Slovakia
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Europe, GmbH
Investigators
Study Chair: Professor Lars Christian Rump, M.D. University of Ruhr-Bochum
  More Information

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 Submitted: February 1, 2007
First Posted: February 2, 2007
Results First Submitted: February 9, 2009
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Hydrochlorothiazide
Olmesartan Medoxomil
Antihypertensive Agents
Diuretics
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