Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 40 mg Monotherapy
1 other identifier
interventional
972
7 countries
55
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
Shorter than P25 for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
June 17, 2009
CompletedJanuary 9, 2019
June 1, 2009
1.1 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 From Week 8(Baseline) to Week 16
Change = Week 16 - Week 8 (baseline).
8 weeks, change = week 16 - week 8
Secondary Outcomes (7)
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
4 weeks, change = week 12 - week 8
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
8 weeks, change = week 16 - week 8
Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
4 weeks, change = week 12 - week 8
Number of Patients Achieving Target Blood Pressure at Week 16
8 weeks
Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
8 weeks, change = week 16 - week 8
- +2 more secondary outcomes
Study Arms (4)
4
EXPERIMENTALolmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1
EXPERIMENTALolmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
3
EXPERIMENTALolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
2
EXPERIMENTALolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Interventions
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Eligibility Criteria
You may qualify if:
- Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)
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 (55)
Unknown Facility
Pleven, Bulgaria
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Sofia, Bulgaria
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Beroun, Czechia
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Brno, Czechia
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Chrudim, Czechia
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Hradec Králové, Czechia
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Jindřichův Hradec, Czechia
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Kutná Hora, Czechia
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Ostrava, Czechia
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Pardubice, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Příbram, Czechia
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Řevnice, Czechia
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Sokolov, Czechia
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Trutnov, Czechia
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Langres, France
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Paris, France
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Pessac, France
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Berlin, Germany
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Bochum, Germany
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Dietzenbach, Germany
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Franfurt, Germany
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Friedberg, Germany
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Ingelheim, Germany
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Karlsbad, Germany
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Leipzig, Germany
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Offenbach, Germany
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Siegen, Germany
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Stuhr-Brinkum, Germany
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Elblag, Poland
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Gdansk, Poland
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Inowrocław, Poland
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Katowice, Poland
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Krakow, Poland
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Linia, Poland
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Lodz, Poland
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Oława, Poland
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Poznan, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Zamość, Poland
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Girona, Spain
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Granada, Spain
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Madrid, Spain
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Oviedo, Spain
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Dnipro, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
Unknown Facility
Uzhhorod, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Unknown Facility
Zaporizhzhya, Ukraine
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
- James McCarthy / Director Regulatory Operations
- 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
Study Record Dates
First Submitted
February 1, 2007
First Posted
February 2, 2007
Study Start
February 1, 2007
Primary Completion
March 1, 2008
Study Completion
May 1, 2008
Last Updated
January 9, 2019
Results First Posted
June 17, 2009
Record last verified: 2009-06
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/