Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

December 20, 2018 updated by: Daiichi Sankyo, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1011

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 weeks
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).
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
Change = Week 16 - Week 8 (baseline).
8 weeks
Number of Participants Achieving Blood Pressure Goal.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Collaborators

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS866CM-B-E302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. 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: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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