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Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

NCT ID: NCT00430508

Last Updated: 2019-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

972 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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4

olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Group Type EXPERIMENTAL

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo

Intervention Type DRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week

1

olmesartan medoxomil (OM) /hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Group Type EXPERIMENTAL

olmesartan medoxomil/hydrochlorothiazide tablets

Intervention Type DRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

3

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

Group Type EXPERIMENTAL

olmesartan medoxomil/hydrochlorothiazide tablets

Intervention Type DRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

2

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Group Type EXPERIMENTAL

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

Intervention Type DRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Interventions

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olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week

Intervention Type DRUG

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Intervention Type DRUG

olmesartan medoxomil/hydrochlorothiazide tablets

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks

Intervention Type DRUG

olmesartan medoxomil/hydrochlorothiazide tablets

olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female Europeans aged 18 years or older with moderate to severe hypertension (HTN)

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Daichi Sankyo Europe, GmbH

Principal Investigators

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Professor Lars Christian Rump, M.D.

Role: STUDY_CHAIR

University of Ruhr-Bochum

Locations

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Pleven, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Beroun, , Czechia

Site Status

Brno, , Czechia

Site Status

Chrudim, , Czechia

Site Status

Hradec Králové, , Czechia

Site Status

Jindřichův Hradec, , Czechia

Site Status

Kutná Hora, , Czechia

Site Status

Ostrava, , Czechia

Site Status

Pardubice, , Czechia

Site Status

Pilsen, , Czechia

Site Status

Prague, , Czechia

Site Status

Příbram, , Czechia

Site Status

Řevnice, , Czechia

Site Status

Sokolov, , Czechia

Site Status

Trutnov, , Czechia

Site Status

Langres, , France

Site Status

Paris, , France

Site Status

Pessac, , France

Site Status

Berlin, , Germany

Site Status

Bochum, , Germany

Site Status

Dietzenbach, , Germany

Site Status

Franfurt, , Germany

Site Status

Friedberg, , Germany

Site Status

Ingelheim, , Germany

Site Status

Karlsbad, , Germany

Site Status

Leipzig, , Germany

Site Status

Offenbach, , Germany

Site Status

Siegen, , Germany

Site Status

Stuhr-Brinkum, , Germany

Site Status

Elblag, , Poland

Site Status

Gdansk, , Poland

Site Status

Inowrocław, , Poland

Site Status

Katowice, , Poland

Site Status

Krakow, , Poland

Site Status

Linia, , Poland

Site Status

Lodz, , Poland

Site Status

Oława, , Poland

Site Status

Poznan, , Poland

Site Status

Warsaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Zamość, , Poland

Site Status

Girona, , Spain

Site Status

Granada, , Spain

Site Status

Madrid, , Spain

Site Status

Oviedo, , Spain

Site Status

Dnipro, , Ukraine

Site Status

Donetsk, , Ukraine

Site Status

Kharkiv, , Ukraine

Site Status

Kiev, , Ukraine

Site Status

Lviv, , Ukraine

Site Status

Odesa, , Ukraine

Site Status

Uzhhorod, , Ukraine

Site Status

Vinnytsia, , Ukraine

Site Status

Zaporizhzhya, , Ukraine

Site Status

Countries

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Bulgaria Czechia France Germany Poland Spain Ukraine

References

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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.

Reference Type DERIVED
PMID: 22114906 (View on PubMed)

Other Identifiers

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CS866CM-B-E301

Identifier Type: -

Identifier Source: org_study_id

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