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 |
| Protocol serial number | CCR-XL001 |
| Sponsor | Connecticut Clinical Research LLC (USA) |
| Funder | Connecticut Clinical Research, LLC |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
4675 Main Street
Bridgeport
06606
United States of America
| Phone | +1 203 683 5111 |
|---|---|
| edward_kosinski@med3000.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized, double-blind, placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | XTEND LIFE Capasule and ezetimibe |
| Primary outcome measure(s) |
To compare the low density lipoprotein cholesterol (LDL-C) lowering efficacy of XTEND-LIFE to placebo in patients with hypercholesterolemia |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
06606
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
