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
Scientific
4675 Main Street
Bridgeport
06606
United States of America
| Phone | +1 203 683 5111 |
|---|---|
| edward_kosinski@med3000.com |
Study information
| Study design | Randomized, double-blind, placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | XTEND LIFE Capasule and ezetimibe |
| Primary outcome measure | 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 study start date | 10/10/2005 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/10/2005 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- United States of America
Study participating centre
4675 Main Street
Bridgeport
06606
United States of America
06606
United States of America
Sponsor information
Connecticut Clinical Research LLC (USA)
Research organisation
Research organisation
4675 Main Street
Bridgeport
06606
United States of America
| Phone | +1 203 683 5130 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
