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Rosiglitazone for Prediabetes-Related Coronary Artery Disease
Study Summary
This trial will study the effects of rosiglitazone on exercise tolerance, coronary artery calcification, and diabetes indicators in subjects with impaired glucose tolerance.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 3 trial • 1791 Patients • NCT00032487Trial Design
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- My blood sugar levels after eating are between 140-199 mg/dL.Your blood sugar levels must be below 126 mg/dL, C-peptide level should be above 2.0 ng/mL, and HbA1c should be less than 6.5%.You have been regularly drinking too much alcohol or using drugs in the past 6 months.I do not have heart or lung conditions that limit my ability to exercise.I take steroids for a chronic condition.I am not on any weight loss medications or programs, nor have I started an intensive exercise program recently.I am not using hormone-based birth control or hormone replacement therapy.I am using effective birth control and will continue for the study duration and 30 days after.I am a woman who can have children and my pregnancy test is negative.I don't have any health issues that would make it unsafe for me to join the study.You have had a strong allergic reaction to thiazolidinediones, like trouble swallowing, breathing, fast heartbeat, or skin problems.You must have a body mass index between 25 and 40, and weigh less than 300 pounds.My liver function tests are within normal limits.I am a woman who is either postmenopausal, surgically sterile, or using effective birth control.I cannot take rosiglitazone due to health reasons.I have severe heart pain or discomfort that needs constant medication.I have had cancer before, but not skin cancer.You are currently smoking.I am between 25 and 75 years old.I have severe heart failure or high blood pressure needing medication.
- Group 1: 1
- Group 2: 2
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research include people who are over 55 years old?
"This trial is open to patients that are aged 25-75."
Is this a new type of clinical trial?
"There have been 60 people involved in Rosiglitazone clinical trials since the drug's inception in 2004. The most recent trial was completed in Phase 4 and sponsored by GlaxoSmithKline. In total, 18377 studies on this medication have been undertaken."
Are there any vacancies in this research for people who want to participate?
"This trial is not recruiting patients at this time. The first posting was on March 1st, 2004 and the most recent edit was on August 11th, 2008. However, there are 748 other trials actively looking for participants with impaired glucose tolerance and 2 trials for Rosiglitazone that are still enrolling patients."
Are there any other drugs in the same class as Rosiglitazone?
"As of now, there are two active studies researching rosiglitazone. Neither of these trials are in phase three. However, several studies for rosiglitazone are running out of locations in Denver, Colorado. Additionally, there are two other clinical trial sites that are currently testing this medication."
Do I fit the profile of patients who can take part in this research?
"Eligible participants for this clinical trial must have impaired glucose tolerance, be between the ages of 25 and 75, and qualify under other criteria set by the study. The researchers conducting this trial need a total of 60 people."
Are there risks associated with taking Rosiglitazone?
"While Phase 4 trials are typically for approved treatments, our team has given Rosiglitazone a score of 3 out of 3 for safety."
How many test subjects are being enrolled in this clinical trial?
"This study is not currently recruiting patients. However, if you are interested in other research opportunities, there are 748 studies actively searching for participants that have impaired glucose tolerance and 2 studies for Rosiglitazone seeking volunteers."
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