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
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