A single-center, double-blind, randomized, placebo-controlled, 13-week study to evaluate the efficacy and safety of one capsule of XTEND-LIFE compared to placebo, and an extended four-week trial to assess its benefit when combined with ezetimibe 10 mg per day

Completed

• Conditions: Hypercholesterolemia; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN36282240
• Lead Sponsor: Connecticut Clinical Research LLC (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Men and women greater than 18 years of age with LDL-C greater than or equal to 130 mg/dl
2. Have not received any cholesterol lowering medication for 8 weeks
3. Patients with coronary heart disease or coronary heart disease risk equivalents and with documented intolerance or reluctance to take Hydroxamethylglutaryl-CoA (HMG-CoA) reductase inhibitors will be included, however, patients being treated with and who are tolerant of HMG-CoA reductase inhibitors will not be considered

Exclusion Criteria

1. Plasma triglycerides >400 mg/dl
2. Congestive Heart Failure (CHF) with New York Heart Association (NYHA) class 3 or 4
3. Hemoglobin A1C >9%
4. Ileal bypass or gastrointestinal (GI) disorder that can impair absorption of study drugs
5. Impaired renal function - aspartate aminotransferase (AST) or alanine transaminase (ALT) >2 times the upper limit of normal
6. Uncontrolled endocrine disorder
7. Alcohol consumption >14 drinks per week
8. Lipid lowering medication within 8 weeks
9. Treatment with oral corticosteroids, immunosuppressants, androgens or warfarin

Study & Design

• Study Type: Interventional
• Study Design: Not specified