Arterial Occlusive DiseasesNCT00154050
High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty
A study testing candesartan (drug) or quinapril (drug) in people with Arterial Occlusive Diseases, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- candesartan (drug) or quinapril (drug)
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female
- peripheral occlusive arterial disease Stad IIb Fontaine classification
Who cannot join
- patients with lesions not available for PTA
- renal insufficiency
- patients on calcium-antagonists
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- candesartan (drug) or quinapril (drug)
- Keywords
- restenosis, intima hyperproliferation, stent angioplasty, pain-free walking distance
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan (drug) or quinapril (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis/reintervention after 6 months
Secondary outcomes (2)
pain-free walking distance
crurobrachial pressure ratios
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Wilhelm Kirch, MD, Study chair, Institute of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154050
- Sponsor's protocol ID
- IKPD KARDCHEM 02-04
- Status last verified
- Sep 2006
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty
- ClinicalTrials.gov ID
- NCT00154050
- Acronym / sponsor ID
- IKPD KARDCHEM 02-04
- Conditions
- Arterial Occlusive Diseases
- Keywords
- restenosis, intima hyperproliferation, stent angioplasty, pain-free walking distance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Jul 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male and female
- peripheral occlusive arterial disease Stad IIb Fontaine classification
Key exclusion criteria (3 listed)
- patients with lesions not available for PTA
- renal insufficiency
- patients on calcium-antagonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| candesartan (drug) or quinapril (drug) | Drug | – |
Primary outcome
Restenosis/reintervention after 6 months
2 secondary outcomes
pain-free walking distance
crurobrachial pressure ratios
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilhelm Kirch, MD study chair
Institute of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing candesartan (drug) or quinapril (drug) in people with Arterial Occlusive Diseases, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restenosis/reintervention after 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2006.