A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00134498

Collaborator

(none)

160

Enrollment

Locations

Duration (Months)

3.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia Hyperlipoproteinemia Type IV	Drug: torcetrapib/atorvastatin Drug: atorvastatin	Phase 3

Detailed Description

For additional information please call: 1-800-718-1021

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia

Study Start Date :

Feb 1, 2005

Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

Change in HDL-C and non-HDL-C levels []

Secondary Outcome Measures

Changes in levels of other lipid and biomarkers. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Fredrickson Type IV Hypertriglyceridemia

Exclusion Criteria:

Women who are pregnant or lactating, or planning to become pregnant.
Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Anaheim	California	United States
2	Pfizer Investigational Site	Huntington Beach	California	United States
3	Pfizer Investigational Site	Los Angeles	California	United States
4	Pfizer Investigational Site	Orangevale	California	United States
5	Pfizer Investigational Site	Orange	California	United States
6	Pfizer Investigational Site	Pacific Palisades	California	United States
7	Pfizer Investigational Site	Studio City	California	United States
8	Pfizer Investigational Site	Tustin	California	United States
9	Pfizer Investigational Site	Walnut Creek	California	United States
10	Pfizer Investigational Site	Farmington	Connecticut	United States
11	Pfizer Investigational Site	Washington	District of Columbia	United States
12	Pfizer Investigational Site	Hollywood	Florida	United States
13	Pfizer Investigational Site	Longwood	Florida	United States
14	Pfizer Investigational Site	West Palm Beach	Florida	United States
15	Pfizer Investigational Site	Tripler AMC	Hawaii	United States
16	Pfizer Investigational Site	Chicago	Illinois	United States
17	Pfizer Investigational Site	Indianapolis	Indiana	United States
18	Pfizer Investigational Site	Overland Park	Kansas	United States
19	Pfizer Investigational Site	Baton Rouge	Louisiana	United States
20	Pfizer Investigational Site	Scarborough	Maine	United States
21	Pfizer Investigational Site	Bethesda	Maryland	United States
22	Pfizer Investigational Site	Ann Arbor	Michigan	United States
23	Pfizer Investigational Site	Canton	Michigan	United States
24	Pfizer Investigational Site	Portage	Michigan	United States
25	Pfizer Investigational Site	Richland	Michigan	United States
26	Pfizer Investigational Site	St. Cloud	Minnesota	United States
27	Pfizer Investigational Site	Olive Branch	Mississippi	United States
28	Pfizer Investigational Site	Jefferson City	Missouri	United States
29	Pfizer Investigational Site	St. Louis	Missouri	United States
30	Pfizer Investigational Site	Las Vegas	Nevada	United States
31	Pfizer Investigational Site	Rochester	New York	United States
32	Pfizer Investigational Site	Syracuse	New York	United States
33	Pfizer Investigational Site	West Seneca	New York	United States
34	Pfizer Investigational Site	Statesville	North Carolina	United States
35	Pfizer Investigational Site	Sellersville	Pennsylvania	United States
36	Pfizer Investigational Site	Warwick	Rhode Island	United States
37	Pfizer Investigational Site	San Antonio	Texas	United States
38	Pfizer Investigational Site	Richmond	Virginia	United States
39	Pfizer Investigational Site	Madison	Wisconsin	United States
40	Pfizer Investigational Site	Halifax	Nova Scotia	Canada
41	Pfizer Investigational Site	London	Ontario	Canada
42	Pfizer Investigational Site	Chicoutimi	Quebec	Canada
43	Pfizer Investigational Site	Montreal	Quebec	Canada
44	Pfizer Investigational Site	Ste-Foy	Quebec	Canada