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Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo (Drug); olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets (Drug); olmesartan medoxomil/hydrochlorothiazide tablets (Drug); olmesartan medoxomil/hydrochlorothiazide tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

Official(s) and/or principal investigator(s):
Professor Lars Christian Rump, M.D., Study Chair, Affiliation: University of Ruhr-Bochum

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16

Secondary outcome:

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.

Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.

Number of Patients Achieving Target Blood Pressure at Week 16

Change in Mean 24-Hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Change in Mean Night-Time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pleven, Bulgaria

Sofia, Bulgaria

Beroun, Czech Republic

Brno, Czech Republic

Chrudim, Czech Republic

Hradec Kralove, Czech Republic

Jindrichuv Hradec, Czech Republic

Kutna Hora, Czech Republic

Ostrava, Czech Republic

Pardubice, Czech Republic

Plzen, Czech Republic

Prague, Czech Republic

Pribram, Czech Republic

Revnice, Czech Republic

Sokolov, Czech Republic

Trutnov, Czech Republic

Langres, France

Paris, France

Pessac, France

Berlin, Germany

Bochum, Germany

Dietzenbach, Germany

Franfurt, Germany

Friedberg, Germany

Ingelheim, Germany

Karlsbad, Germany

Leipzig, Germany

Offenbach, Germany

Siegen, Germany

Stuhr-Brinkum, Germany

Elblag, Poland

Gdansk, Poland

Inowroclaw, Poland

Katowice, Poland

Krakow, Poland

Linia, Poland

Lodz, Poland

Olawa, Poland

Poznan, Poland

Warszawa, Poland

Wroclaw, Poland

Zamosc, Poland

Girona, Spain

Granada, Spain

Madrid, Spain

Oviedo, Spain

Dnepropetrovsk, Ukraine

Donetsk, Ukraine

Kharkiv, Ukraine

Kiev, Ukraine

Lviv, Ukraine

Odessa, Ukraine

Uzhgorod, Ukraine

Vinnytsia, Ukraine

Zaporizhzhya, Ukraine

Additional Information

Starting date: February 2007
Last updated: June 17, 2009

Page last updated: August 23, 2015

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