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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00154050
Other study ID # IKPD KARDCHEM 02-04
Secondary ID
Status Completed
Phase N/A
First received September 8, 2005
Last updated September 11, 2006
Start date May 2004
Est. completion date July 2006

Study information

Verified date September 2006
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
candesartan (drug) or quinapril (drug)


Locations

Country Name City State
Germany Chemnitz Hospital, Dept. of Internal Medicine I Chemnitz

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Restenosis/reintervention after 6 months
Secondary pain-free walking distance
Secondary crurobrachial pressure ratios
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