Not Signed In -
Candesartan |
Atacand; candesartan cilexetil |
Clinical Trial: High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty in Peripheral Occlusive Artery Disease.
This study is currently recruiting patients.
Verified by Dresden University of Technology September 2005
|
Purpose
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.
| Condition | Intervention |
|---|---|
| occlusive arterial disease | Drug: candesartan (drug) or quinapril (drug) |
MedlinePlus related topics: Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: Restenosis/reintervention after 6 months
Secondary Outcomes: pain-free walking distance; crurobrachial pressure ratios
Expected Total Enrollment: 22
Secondary Outcomes: pain-free walking distance; crurobrachial pressure ratios
Expected Total Enrollment: 22
Study start: May 2004; Expected completion: May 2006
Last follow-up: February 2006; Data entry closure: April 2006
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.
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00154050
Christoph Schindler, MD +493514582027 christoph.schindler@tu-dresden.de
Germany
Chemnitz Hospital, Dept. of Internal Medicine I, Chemnitz, 09313, Germany; Recruiting
Christoph Schindler, MD
Johannes Schweizer, MD, Principal Investigator
Johannes Schweizer, MD, Principal Investigator
Study chairs or principal investigators
Wilhelm Kirch, MD, Study Chair, Institute of Clinical Pharmacology
More Information
Study ID Numbers: IKPD KARDCHEM 02-04
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154050
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154050
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Atacand (Drug Digest)
- Atacand Consumer Information (U.S. Food and Drug Administration)
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