Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
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
1 other identifier
interventional
1,011
4 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
April 20, 2009
CompletedJanuary 10, 2019
October 1, 2017
1.2 years
February 1, 2007
February 9, 2009
December 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mean Trough Sitting Diastolic Blood Pressure
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 Outcomes (4)
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
4 weeks
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
8 weeks
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
8 weeks
Number of Participants Achieving Blood Pressure Goal.
8 weeks
Study Arms (2)
1
EXPERIMENTALolmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
2
EXPERIMENTALolmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo
Interventions
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
Eligibility Criteria
You may qualify if:
- Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Bruges, Belgium
Unknown Facility
Brussels, Belgium
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Drongen, Belgium
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Godinne, Belgium
Unknown Facility
Mouscron, Belgium
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Wetteren, Belgium
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Berlin, Germany
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Dortmund, Germany
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Essen, Germany
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Frankfurt, Germany
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Goch, Germany
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Hamburg, Germany
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Kallstadt, Germany
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Karlsruhe, Germany
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Kassel, Germany
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Magdeburg, Germany
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Marburg, Germany
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München, Germany
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Wiesbaden, Germany
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Wuppertal, Germany
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's-Hertogenbosch, Netherlands
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Alphen aan den Rijn, Netherlands
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Amsterdam-Zuidoost, Netherlands
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Andijk, Netherlands
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De Bilt, Netherlands
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Ewijk, Netherlands
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Heerlen, Netherlands
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Hengelo, Netherlands
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Landgraaf, Netherlands
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Nijmegen, Netherlands
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Oud-Beijerland, Netherlands
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Ridderkerk, Netherlands
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The Hague, Netherlands
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Wildervank, Netherlands
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Zwijndrecht, Netherlands
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Bratislava, Slovakia
Unknown Facility
Levice, Slovakia
Unknown Facility
Lučenec, Slovakia
Unknown Facility
Nitra, Slovakia
Unknown Facility
Nové Zámky, Slovakia
Unknown Facility
Vráble, Slovakia
Related Publications (1)
Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.
PMID: 22114906DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Leader
- Organization
- Daiichi Sankyo
Study Officials
- STUDY CHAIR
Professor Lars Christian Rump, M.D.
University of Ruhr-Bochum
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2007
First Posted
February 2, 2007
Study Start
February 1, 2007
Primary Completion
May 1, 2008
Study Completion
October 1, 2008
Last Updated
January 10, 2019
Results First Posted
April 20, 2009
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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/