Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Collaborator:	Daiichi Sankyo Europe, GmbH
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00430950

Purpose

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.

Condition	Intervention	Phase
Essential Hypertension	Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change in Mean Trough Sitting Diastolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change in Daytime, Nighttime and 24-Hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Number of Participants Achieving Blood Pressure Goal. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	1011
Study Start Date:	February 2007
Study Completion Date:	October 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo	Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
2: Experimental olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo	Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430950

Locations

Belgium

Wetteren, Belgium

Brugge, Belgium

Mouscron, Belgium

Drongen, Belgium

Brussels, Belgium

Mont-Godinne, Belgium
Germany

Karlsruhe, Germany

Marburg, Germany

Kassel, Germany

Goch, Germany

Berlin, Germany

Muenchen, Germany

Magdeburg, Germany

Frankfurt, Germany

Dortmund, Germany

Wuppertal, Germany

Hamburg, Germany

Wiesbaden, Germany

Essen, Germany

Kallstadt, Germany
Netherlands

Ewijk, Netherlands

Wildervank, Netherlands

Hengelo, Netherlands

Heerlen, Netherlands

Landgraaf, Netherlands

Nijmegen, Netherlands

Andijk, Netherlands

Zwijndrecht, Netherlands

Alphen aan de Rijn, Netherlands

De Bilt, Netherlands

Amsterdam Zuidoost, Netherlands

Den Bosch, Netherlands

Oud-Beijerland, Netherlands

Den Haag, Netherlands

Ridderkerk, Netherlands

Levice, Netherlands
Slovakia

Levice, Slovakia

Nitra, Slovakia

Nove Zamky, Slovakia

Vrable, Slovakia

Lucenec, Slovakia

Bratislava, Slovakia

Sponsors and Collaborators

Daiichi Sankyo Inc.

Daiichi Sankyo Europe, GmbH

Investigators

Study Chair:

Professor Lars Christian Rump, M.D.

University of Ruhr-Bochum

More Information

No publications provided

Responsible Party:	Daichi Sankyo Europe, GmbH ( Dr. Bettina Ammentorp )
Study ID Numbers:	CS866CM-B-E302
Study First Received:	February 1, 2007
Results First Received:	February 9, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00430950 History of Changes
Health Authority:	EU: EMEA; Germany: Bundesministerium fur Gesundeheit und Soziale Sicherung; The Netherlands: Staatstoezicht op de volksgezondheid; Ukraine: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Belgium: Directorate general for the protection of Public health: Medicines; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Daiichi Sankyo Inc.:

Moderate-to-Severe Hypertension
Essential Hypertension
Combination Therapy
Fixed-Combination Dose

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010