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

ISRCTN ISRCTN36282240
DOI https://doi.org/10.1186/ISRCTN36282240
Secondary identifying numbers CCR-XL001
Submission date
23/03/2006
Registration date
27/04/2006
Last edited
02/05/2006
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Edward Kosinski
Scientific

4675 Main Street
Bridgeport
06606
United States of America

Phone +1 203 683 5111
Email edward_kosinski@med3000.com

Study information

Study designRandomized, double-blind, placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesXTEND-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.
Ethics approval(s)Approved by the Western Institutional Review Board (WIRB) on 29/09/2005, study number: 1069148, WIRB protocol number: 20051297
Health condition(s) or problem(s) studiedHypercholesterolemia
InterventionThe 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)XTEND LIFE Capasule and ezetimibe
Primary outcome measureTo compare the low density lipoprotein cholesterol (LDL-C) lowering efficacy of XTEND-LIFE to placebo in patients with hypercholesterolemia
Secondary outcome measures1. 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
Overall study start date10/10/2005
Completion date31/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment10/10/2005
Date of final enrolment31/07/2006

Locations

Countries of recruitment

  • United States of America

Study participating centre

4675 Main Street
Bridgeport
06606
United States of America

Sponsor information

Connecticut Clinical Research LLC (USA)
Research organisation

4675 Main Street
Bridgeport
06606
United States of America

Phone +1 203 683 5130
Email maria_capasso@med3000.com

Funders

Funder type

Industry

Connecticut Clinical Research, LLC

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan