Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00245388
Collaborator
(none)
330
54
3
6.1
2
Study Details
Study Description
Brief Summary
This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Trial to Determine the Lipid-Lowering Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
Study Start Date
:
Apr 1, 2002
Actual Study Completion Date
:
Jul 1, 2002
Outcome Measures
Primary Outcome Measures
- To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg []
Secondary Outcome Measures
- Percent changes from baseline to average at week 5-6 of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, apolipoprotein A1 (ApoA1), and free fatty acid (FFA) levels []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Non-diabetics
-
Serum TG >150 mg/dL and < or = 600 mg/dL
-
Serum LDL-C >130 mg/dL
Exclusion Criteria:
-
Type 1 or type 2 diabetics
-
Fasting plasma glucose >126 mg/dL
-
Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):
-
Niacin or bile-acid binding agents and HMG CoA reductase inhibitors: 8 weeks
-
Fibrates: 8 weeks
-
Probucol: 1 year
-
History of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Phoenix | Arizona | United States | |
| 2 | Local Institution | Little Rock | Arkansas | United States | |
| 3 | Local Institution | Irvine | California | United States | |
| 4 | Local Institution | Long Beach | California | United States | |
| 5 | Local Institution | Raleigh | California | United States | |
| 6 | Local Institution | Roseville | California | United States | |
| 7 | Local Institution | Sacramento | California | United States | |
| 8 | Local Institution | San Diego | California | United States | |
| 9 | Local Institution | Santa Ana | California | United States | |
| 10 | Local Institution | Longmont | Colorado | United States | |
| 11 | Local Institution | Clearwater | Florida | United States | |
| 12 | Local Institution | Cooper City | Florida | United States | |
| 13 | Local Institution | Deland | Florida | United States | |
| 14 | Local Institution | Inverness | Florida | United States | |
| 15 | Local Institution | Longwood | Florida | United States | |
| 16 | Local Institution | Pembroke Pines | Florida | United States | |
| 17 | Local Institution | Sarasota | Florida | United States | |
| 18 | Local Institution | Stuart | Florida | United States | |
| 19 | Local Institution | Dunwoody | Georgia | United States | |
| 20 | Local Institution | Melbourne | Georgia | United States | |
| 21 | Local Institution | Peoria | Illinois | United States | |
| 22 | Local Institution | Indianapolis | Indiana | United States | |
| 23 | Local Institution | Iowa City | Iowa | United States | |
| 24 | Local Institution | Overland Park | Kansas | United States | |
| 25 | Local Institution | Wichita | Kansas | United States | |
| 26 | Local Institution | Louisville | Kentucky | United States | |
| 27 | Local Institution | Marrero | Louisiana | United States | |
| 28 | Local Institution | Baltimore | Maryland | United States | |
| 29 | Local Institution | Bethesda | Maryland | United States | |
| 30 | Local Institution | Edina | Minnesota | United States | |
| 31 | Local Institution | Minneapolis | Minnesota | United States | |
| 32 | Local Institution | Kansas City | Missouri | United States | |
| 33 | Local Institution | Saint Louis | Missouri | United States | |
| 34 | Local Institution | Toms River | New Jersey | United States | |
| 35 | Local Institution | Manlius | New York | United States | |
| 36 | Local Institution | Hickory | North Carolina | United States | |
| 37 | Local Institution | Winston-Salem | North Carolina | United States | |
| 38 | Local Institution | Columbus | Ohio | United States | |
| 39 | Local Institution | Bend | Oregon | United States | |
| 40 | Local Institution | Hillsboro | Oregon | United States | |
| 41 | Local Institution | Portland | Oregon | United States | |
| 42 | Local Institution | Philadelphia | Pennsylvania | United States | |
| 43 | Local Institution | Sellersville | Pennsylvania | United States | |
| 44 | Local Institution | Warminster | Pennsylvania | United States | |
| 45 | Local Institution | Greer | South Carolina | United States | |
| 46 | Local Institution | Mount Pleasant | South Carolina | United States | |
| 47 | Local Institution | Austin | Texas | United States | |
| 48 | Local Institution | Dallas | Texas | United States | |
| 49 | Local Institution | San Angelo | Texas | United States | |
| 50 | Local Institution | San Antonio | Texas | United States | |
| 51 | Local Institution | Olympia | Washington | United States | |
| 52 | Local Institution | Seattle | Washington | United States | |
| 53 | Local Institution | Yakima | Washington | United States | |
| 54 | Local Institution | Ottawa | Ontario | Canada |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00245388
Other Study ID Numbers:
- CV168-008
First Posted:
Oct 28, 2005
Last Update Posted:
Apr 23, 2012
Last Verified:
Apr 1, 2012