- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00160160
Comparison of Eprosartan/HCT Versus Enalapril/HCT in Hypertensives With Type II Diabetes
January 29, 2009 updated by: Solvay Pharmaceuticals
A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2
This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
440
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Calgary, Canada
- Site 26
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Montreal, Canada
- Site 27
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Quebec, Canada
- Site 30
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Thornhill, Canada
- Site 31
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Vancouver, Canada
- Site 28
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Winnipeg, Canada
- Site 29
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Holbaek, Denmark
- Site 39
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Roskilde, Denmark
- Site 38
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Viborg, Denmark
- Site 40
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Anzin, France
- Site 4
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Blois, France
- Site 3
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Chemellier, France
- Site 10
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Cholet, France
- Site 11
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Cholet, France
- Site 15
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Cholet, France
- Site 16
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La Jubaudiere, France
- Site 14
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Le Mesnil-en-Vallee, France
- Site 13
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Murs-Erigne, France
- Site 7
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Saumur, France
- Site 9
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Segre, France
- Site 8
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St Pierre Montlim, France
- Site 12
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Thouars, France
- Site 6
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Tours, France
- Site 2
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Vieux Conde, France
- Site 5
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Bad Muenster, Germany
- Site 20
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Floersheim, Germany
- Site 22
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Kirweiler, Germany
- Site 19
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Lambrecht, Germany
- Site 21
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Lindau, Germany
- Site 25
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Lueneburg, Germany
- Site 18
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Lutherstadt, Germany
- Site 24
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Riesa, Germany
- Site 17
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Waldbrunn, Germany
- Site 23
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Bologna, Italy
- Site 62
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Napoli, Italy
- Site 60
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Padova, Italy
- Site 58
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Palermo, Italy
- Site 59
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Pavia, Italy
- Site 63
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Pisa, Italy
- Site 61
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Torino, Italy
- Site 64
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Alesund, Norway
- Site 43
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Bergen, Norway
- Site 42
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Horten, Norway
- Site 44
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Skedsmokorset, Norway
- Site 41
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Badajoz, Spain
- Site 55
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Badalona, Spain
- Site 51
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Barcelona, Spain
- Site 56
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Barcelona, Spain
- Site 57
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Ciudad Real, Spain
- Site 54
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Granada, Spain
- Site 53
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Madrid, Spain
- Site 52
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Angelholm, Sweden
- Site 48
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Goteburg, Sweden
- Site 47
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Helsingborg, Sweden
- Site 46
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Kristianstat, Sweden
- Site 45
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Malmo, Sweden
- Site 50
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Stockholm, Sweden
- Site 49
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Aberdeen, United Kingdom
- Site 33
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Bath, United Kingdom
- Site 36
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Liverpool, United Kingdom
- Site 37
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Manchester, United Kingdom
- Site 34
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Oldham, United Kingdom
- Site 32
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Rugby, United Kingdom
- Site 35
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- essential hypertension,
- diabetes type 2
Exclusion Criteria:
- severe cardiovascular disease,
- grade 3 hypertension,
- secondary hypertension,
- abnormal liver enzymes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Blood pressure reduction
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Secondary Outcome Measures
Outcome Measure |
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Comparison of responder rates
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
January 30, 2009
Last Update Submitted That Met QC Criteria
January 29, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Hypertension
- Diabetes Mellitus
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin Receptor Antagonists
- Angiotensin II Type 2 Receptor Blockers
- Eprosartan
Other Study ID Numbers
- S171.3.012
- 2004-00703-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
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National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
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University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
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BayerCompletedPrimary HypertensionChina
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Addpharma Inc.Recruiting
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Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
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Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
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Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
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Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
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Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on eprosartan/HCTZ
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AbbottQuintiles, Inc.; Synexus; author! et al. BVCompletedEssential HypertensionGermany, Russian Federation, United Kingdom
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Medical University of LodzCompletedUric Acid Concentration, Serum, Quantitative Trait Locus 7
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University of Missouri-ColumbiaCompleted
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NovartisCompleted
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NovartisCompletedHypertensionUnited States, Germany
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Vanderbilt University Medical CenterCompletedHigh Blood PressureUnited States
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Boryung Pharmaceutical Co., LtdChonbuk National University Hospital; Samsung Medical Center; Asan Medical Center and other collaboratorsCompletedEssential HypertensionKorea, Republic of
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NovartisCompleted
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VA Office of Research and DevelopmentCompleted
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Merck Sharp & Dohme LLCTerminatedHypertension | Type 2 Diabetes Mellitus