High Dose Candesartan Versus Quinapril for Restenosis Pro... | NCT00154050

Studies
High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

NCT00154050

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Sep 12, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Arterial Occlusive Diseases

Interventions

candesartan (drug) or quinapril (drug)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Jul 2006

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2006

Last Update Posted Date

Sep 12, 2006Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
candesartan (drug) or quinapril (drug)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Restenosis/reintervention after 6 months

Secondary Outcomes

Measure	Description	Time Frame
pain-free walking distance
crurobrachial pressure ratios

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wilhelm Kirch, MD	Institute of Clinical Pharmacology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chemnitz Hospital, Dept. of Internal Medicine I		Chemnitz		09313	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001157	Arterial Occlusive Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C081643	candesartan
D004364	Pharmaceutical Preparations
D000077583	Quinapril

Ancestor Terms

ID	Term
D044005	Tetrahydroisoquinolines
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided