Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/03/2006
Date assigned
27/04/2006
Last edited
02/05/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes