Contact information
Type
Scientific
Primary contact
Dr Edward Kosinski
ORCID ID
Contact details
4675 Main Street
Bridgeport
06606
United States of America
+1 203 683 5111
edward_kosinski@med3000.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCR-XL001
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Approved by the Western Institutional Review Board (WIRB) on 29/09/2005, study number: 1069148, WIRB protocol number: 20051297
Study design
Randomized, double-blind, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hypercholesterolemia
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
XTEND LIFE Capasule and ezetimibe
Primary outcome measures
To compare the low density lipoprotein cholesterol (LDL-C) lowering efficacy of XTEND-LIFE to placebo in patients with hypercholesterolemia
Secondary outcome measures
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
Overall trial start date
10/10/2005
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
10/10/2005
Recruitment end date
31/07/2006
Locations
Countries of recruitment
United States of America
Trial participating centre
4675 Main Street
Bridgeport
06606
United States of America
Sponsor information
Organisation
Connecticut Clinical Research LLC (USA)
Sponsor details
4675 Main Street
Bridgeport
06606
United States of America
+1 203 683 5130
maria_capasso@med3000.com
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Connecticut Clinical Research, LLC
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary