Efficacy Study of Pioglitazone and Atorvastatin Combination Therapy in Treating Subjects With Elevated Risk for Cardiovascular Disease

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and atorvastatin combination therapy compared to atorvastatin monotherapy in patients at risk for cardiovascular disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Atorvastatin; Atorvastatin Calcium; Pioglitazone

Criteria

Inclusion Criteria:

• Intima-media thickness of Common Carotid Artery greater than or equal to 0.8 mm (at least on one side).

• Increased cardiovascular risk defined as one or more of the following:

• medical history of infarction

• coronary angiography with proven cardiovascular disease

• instable Angina pectoris

• duplex-sonography of cervical or leg vessels with proven atherosclerotic vascular alterations

• electrocardiogram with ischemia

• stroke

• transient ischemic attack

• peripheral arterial occlusion

• vessel surgery

• hypertension (RR greater than 140/90)

• antihypertensives

• high density lipoprotein less than 40 mg/dl.

• Body mass index greater than or equal to 25 kg/m2.

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

• History of overt type-2-diabetes according to the World Health Organization criteria.

• History of type-1-diabetes.

• History of more than one unexplained hypoglycemic episode within the last 6 months.

• Statin therapy within the last 4 weeks.

• Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.

• History of severe or multiple allergies.

• Treatment with any other investigational drug within 3 months before trial entry.

• Progressive fatal disease.

• Myopathy.

• Drug or alcohol abuse within the last 5 years.

• Smoker defined as patient with evidence or history of tobacco or nicotine use within the last 6 months before the screening visit.

• A history of heart failure (New York Heart Association stage II - IV) or significant respiratory, gastrointestinal, hepatic (glutamate-pyruvate-transaminase time greater than 2.5 times the normal reference range), renal (creatinine greater than 2.0 mg/dl) or hematological disease.

• Blood donation within the last 30 days.

• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

• ciclosporin

• erythromycin

• clarithromycin

• itraconazole

• ketoconazole

• nefazodone

• niacin

• gemfibrozil and other fibrates

• HIV-Protease-Inhibitors

• Pre-treatment with thiazolidinediones within 3 months before trial entry.