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| Sponsor: | Royal Brompton & Harefield NHS Foundation Trust |
|---|---|
| Collaborators: |
GlaxoSmithKline CORDA, The Heart Charity |
| Information provided by: | Royal Brompton & Harefield NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00123227 |
Purpose
The purpose of this study is to determine whether rosiglitazone, a peroxisome proliferator activated receptor gamma (PPAR-gamma) agonist, induces regression in carotid atherosclerotic plaques in diabetic patients with vascular disease and/or hypertension over a 12 month period.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 Vascular Diseases Hypertension |
Drug: Rosiglitazone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Cardiovascular Magnetic Resonance (CMR) Study to Evaluate the Effect of Rosiglitazone on Carotid Atherosclerotic Plaques in Type 2 Diabetics With Vascular Disease or Hypertension |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | May 2005 |
Rosiglitazone is a new member of the thiazolidinediones (TZDs), a class of drugs which act by binding to peroxisome proliferator activated receptor gamma (PPAR-gamma). It has been suggested that the TZD class od anti-diabetic drug may exhibit anti-atherosclerotic effects. The aim of this study is to evaluate over a 12 month period the potential benefits of rosiglitazone on carotid artery atherosclerotic plaques in the type 2 diabetic population with coexisting vascular disease or hypertension. It is hypothesised that treatment with rosiglitazone will lead to a decrease in plaque size. In addition it is hoped that rosiglitazone will have a positive effect on the plaque composition and stability.
The primary endpoint will be the plaque volume change over 12 months as assessed by cardiovascular magnetic resonance (CMR). The effectiveness of this modality to evaluate the effects of pharmacological agents on atherosclerosis in vivo has been demonstrated in previous studies using statins.
The secondary endpoints will be to define the changes in plaque lipid content, fibrous cap thickness and gadolinium enhancement as a measure of fibrous cap inflammation and plaque neovascularisation.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital | |
| London, United Kingdom, SW3 6NP | |
| St Mary's NHS Trust | |
| London, United Kingdom, W2 1NY | |
| Principal Investigator: | Dudley J Pennell, MD FRCP FACC | Cardiovascular Magnetic Resonance Unit, Royal Brompton Hospital, London UK / National Heart and Lung Institute, Imperial College, London UK |
More Information
| Study ID Numbers: | 02-210 |
| Study First Received: | July 19, 2005 |
| Last Updated: | July 29, 2005 |
| ClinicalTrials.gov Identifier: | NCT00123227 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Randomised controlled trial Rosiglitazone Cardiovascular magnetic resonance |
Diabetes Mellitus Vascular Diseases Hypertension |
|
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Vascular Diseases Diabetes Mellitus |
Endocrine System Diseases Cardiovascular Diseases Glucose Metabolism Disorders Rosiglitazone Pharmacologic Actions Hypertension |