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ISRCTN
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ISRCTN36282240
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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CCR-XL001
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Study hypothesis
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XTEND-LIFE treatment for 12 weeks results in significantly greater reduction in low-density lipoprotein (LDL-C) than treatment with placebo. The addition of ezetimibe further enhances the efficacy of XTEND-LIFE to lower LDL-C.
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Lay summary
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Ethics approval
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Approved by the Western Institutional Review Board (WIRB) on 29/09/2005, study number: 1069148, WIRB protocol number: 20051297
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Study design
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Randomized, double-blind, placebo-controlled study
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Hypercholesterolemia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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10/10/2005
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Anticipated end date
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31/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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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.
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Primary outcome measure(s)
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To compare the low density lipoprotein cholesterol (LDL-C) lowering efficacy of XTEND-LIFE to placebo in patients with hypercholesterolemia
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Secondary outcome measure(s)
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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
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Sources of funding
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Connecticut Clinical Research, LLC
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Trial website
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Publications
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Contact name
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Dr
Edward
Kosinski
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Address
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4675 Main Street
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City/town
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Bridgeport
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Zip/Postcode
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06606
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Country
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United States of America
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Tel
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+1 203 683 5111
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Fax
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+1 203 683 5146
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Email
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edward_kosinski@med3000.com
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Sponsor
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Connecticut Clinical Research LLC (USA)
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Address
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4675 Main Street
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City/town
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Bridgeport
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Zip/Postcode
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06606
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Country
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United States of America
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Tel
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+1 203 683 5130
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Fax
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+1 203 683 5146
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Email
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maria_capasso@med3000.com
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Date applied
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23/03/2006
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Last edited
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02/05/2006
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Date ISRCTN assigned
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27/04/2006
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