Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Condition(s) targeted: Essential Hypertension

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

Phase: Phase 3

Status: Recruiting

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

Overall contact:
Dr. Lars Christian Rump, MD, PhD, Phone: 004923234991670, Email: Christian.Rump@ruhr-uni-bochum.de

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.

Official title: Efficacy and Safety of Hydrochlorothiazide Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Reduction in sitting diastolic blood pressure compared between treatment groups.

Secondary outcome:

Reduction in sitting systolic blood pressure.

Reduction in daytime, nighttime and 24-hr blood pressure evaluated by ABPM.

Percentage of patients achieving BP goal.

Safety and tolerability.

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 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.

Dr. Lars Christian Rump, MD, PhD, Phone: 004923234991670, Email: Christian.Rump@ruhr-uni-bochum.de

Sofia, Bulgaria; Recruiting

Pleven, Bulgaria; Recruiting

Trutnov, Czech Republic; Recruiting

Prague, Czech Republic; Recruiting

Sokolov, Czech Republic; Recruiting

Hradec Kralove, Czech Republic; Recruiting

Jindrichuv Hradec, Czech Republic; Recruiting

Pribram, Czech Republic; Recruiting

Pardubice, Czech Republic; Recruiting

Brno, Czech Republic; Recruiting

Ostrava, Czech Republic; Recruiting

Chrudim, Czech Republic; Recruiting

Kutna Hora, Czech Republic; Recruiting

Revnice, Czech Republic; Recruiting

Beroun, Czech Republic; Recruiting

Plzen, Czech Republic; Recruiting

Langres, France; Recruiting

Paris, France; Recruiting

PESSAC, France; Recruiting

Stuhr-Brinkum, Germany; Recruiting

Franfurt, Germany; Recruiting

Friedberg, Germany; Recruiting

Berlin, Germany; Recruiting

Offenbach, Germany; Recruiting

Dietzenbach, Germany; Recruiting

Ingelheim, Germany; Recruiting

Siegen, Germany; Recruiting

Bochum, Germany; Recruiting

Leipzig, Germany; Recruiting

Karlsbad, Germany; Recruiting

Wroclaw, Poland; Recruiting

Olawa, Poland; Recruiting

Krakow, Poland; Recruiting

Lodz, Poland; Recruiting

Elblag, Poland; Recruiting

Inowroclaw, Poland; Recruiting

Poznan, Poland; Recruiting

Zamosc, Poland; Recruiting

Warszawa, Poland; Recruiting

Gdansk, Poland; Recruiting

Katowice, Poland; Recruiting

Linia, Poland; Recruiting

Granada, Spain; Recruiting

Madrid, Spain; Recruiting

Girona, Spain; Recruiting

Oviedo, Spain; Recruiting

Kiev, Ukraine; Recruiting

Dnepropetrovsk, Ukraine; Recruiting

Donetsk, Ukraine; Recruiting

Vinnytsia, Ukraine; Recruiting

Zaporizhzhya, Ukraine; Recruiting

Kharkiv, Ukraine; Recruiting

Odessa, Ukraine; Recruiting

Lviv, Ukraine; Recruiting

Uzhgorod, Ukraine; Recruiting

Starting date: February 2007
Ending date: June 2008
Last updated: December 26, 2007