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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36282240

Enrollment

Registered

2006-04-27

Start date

2005-10-10

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia Nutritional, Metabolic, Endocrine Hypercholesterolemia

Interventions

The study will compare 12 weeks of treatment with one capsule of XTEND-LIFE to placebo. After 12 weeks, ezetimibe 10 mg/day will be added.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To compare the low density lipoprotein cholesterol (LDL-C) lowering efficacy of XTEND-LIFE to placebo in patients with hypercholesterolemia	—

Secondary

Measure	Time frame
1. To evaluate the effect of XTEND-LIFE compared to placebo on total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglycerides, non-HDL-C, LDL-C:HDL-C ratio, apolipoprotein-B, apolipoprotein-A1, and high sensitivity C reactive protein 2. To evaluate the effect of XTEND-LIFE plus ezetimibe compared to ezetimibe and placebo on total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), triglycerides, non-HDL-C, LDL-C:HDL-C ratio, apolipoprotein-B, apolipoprotein-A1, and high sensitivity C reactive protein 3. To explore the safety and tolerability of XTEND-LIFE with and without ezetimibe	—

Measure

Time frame

1. To evaluate the effect of XTEND-LIFE compared to placebo on total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglycerides, non-HDL-C, LDL-C:HDL-C ratio, apolipoprotein-B, apolipoprotein-A1, and high sensitivity C reactive protein 2. To evaluate the effect of XTEND-LIFE plus ezetimibe compared to ezetimibe and placebo on total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), triglycerides, non-HDL-C, LDL-C:HDL-C ratio, apolipoprotein-B, apolipoprotein-A1, and high sensitivity C reactive protein 3. To explore the safety and tolerability of XTEND-LIFE with and without ezetimibe

—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026