- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00154050
High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty
September 11, 2006 updated by: Technische Universität Dresden
The study is designed to test the hypothesis that high dose candesartan treatment compared to quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent angioplasty in peripheral occlusive artery disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients are randomly assigned to treatment with either candesartan 32 mg/d or Quinapril 20 mg/d before the angioplasty.
Walking distance, intima media thickness and crurobrachial pressure ratios are compared after 6 weeks, 3 months and 6 months.
After 6 months an angiographic control is performed.
Study Type
Interventional
Enrollment
22
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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Chemnitz, Germany, 09313
- Chemnitz Hospital, Dept. of Internal Medicine I
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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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male and female
- peripheral occlusive arterial disease Stad IIb Fontaine classification
Exclusion Criteria:
- patients with lesions not available for PTA
- renal insufficiency
- patients on calcium-antagonists
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
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Restenosis/reintervention after 6 months
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Secondary Outcome Measures
Outcome Measure |
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pain-free walking distance
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crurobrachial pressure ratios
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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
May 1, 2004
Study Completion
July 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (ESTIMATE)
September 12, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 12, 2006
Last Update Submitted That Met QC Criteria
September 11, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arterial Occlusive Diseases
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Angiotensin-Converting Enzyme Inhibitors
- Candesartan
- Quinapril
Other Study ID Numbers
- IKPD KARDCHEM 02-04
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 Arterial Occlusive Diseases
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Meshalkin Research Institute of Pathology of CirculationCompletedARTERIAL OCCLUSIVE DISEASERussian Federation
-
Medical Scientific Fund of the Mayor of ViennaCompletedPeripheral Arterial Occlusive DiseaseAustria
-
SanofiCompletedPeripheral Arterial Occlusive DiseaseUnited States, Finland
-
SanofiCompletedPeripheral Arterial Occlusive DiseaseUnited States, Switzerland
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Ryazan State Medical UniversityRecruitingPeripheral Arterial Occlusive DiseaseRussian Federation
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B. Braun Melsungen AGActive, not recruitingPeripheral Arterial Occlusive DiseaseGermany
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Maquet CardiovascularCompletedPeripheral Arterial Occlusive DiseaseUnited States, Germany, Czechia
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University Hospital Inselspital, BerneWithdrawnPeripheral Arterial Occlusive DiseaseSwitzerland
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Flanders Medical Research ProgramAngioScore, Inc.CompletedPeripheral Arterial Occlusive DiseaseBelgium, Germany
-
Hull University Teaching Hospitals NHS TrustWithdrawnPeripheral Arterial Occlusive DiseaseUnited Kingdom
Clinical Trials on candesartan (drug) or quinapril (drug)
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JW PharmaceuticalCompleted
-
JW PharmaceuticalCompleted
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JW PharmaceuticalCompletedHealthyKorea, Republic of
-
Technische Universität DresdenCompletedHealthy SubjectsGermany
-
University of ZurichUniversity Hospital, Zürich; Center of Competence Multimorbidity, ZurichCompletedDiabetes Complications | Gastrointestinal Hemorrhage | MultimorbiditySwitzerland
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JW PharmaceuticalCompletedHealthyKorea, Republic of
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JULIANA AQUINO DE MOURACompleted
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University Hospital, MontpellierCompleted
-
Sahlgrenska University Hospital, SwedenUppsala University; The Swedish Research Council; Swedish Heart Lung Foundation; The Swedish National Registry for Vascular SurgeryActive, not recruitingPeripheral Arterial Disease | Intermittent Claudication | Critical Limb IschemiaSweden
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Psychiatric Hospital of AtticaThriassio General Hospital of ElefsinaCompletedSurgical Procedure, Unspecified | General Medical ConditionGreece