Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
Sponsor
Solvay Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00362934
Collaborator
(none)
516
68
2
22
7.6
0.3
Study Details
Study Description
Brief Summary
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
516 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone
Study Start Date
:
Oct 1, 2006
Actual Primary Completion Date
:
Aug 1, 2008
Actual Study Completion Date
:
Aug 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: fenofibrate / simvastatin
Combination of fenofibrate and simvastatin 20 mg and 40 mg
|
| Active Comparator: 2
|
Drug: Atorvastatin
Atorvastatin 10 mg and 20mg
|
Outcome Measures
Primary Outcome Measures
- Percent change from baseline to 12 weeks of treatment in Triglycerides [12 weeks]
- Percent change from baseline to 12 weeks of treatment in HDL-C [12 weeks]
- Percent change from baseline to 12 weeks of treatment in LDL-C [12 weeks]
Secondary Outcome Measures
- Percent change from baseline to 12 weeks of treatment in Triglycerides [24 weeks]
- Percent change from baseline to 12 weeks of treatment in HDL-C [24 weeks]
- Percent change from baseline to 12 weeks of treatment in LDL-C [24 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Mixed dyslipidemia.
Exclusion Criteria:
-
Known hypersensitivity to fenofibrates or simvastatin or atorvastatin
-
Pregnant or lactating women
-
Contra-indication to fenofibrate or simvastatin or atorvastatin
-
Unstable or severe cardiac disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 501 | Haskovo | Bulgaria | ||
| 2 | Site 505 | Pleven | Bulgaria | ||
| 3 | Site 503 | Plovdiv | Bulgaria | ||
| 4 | Site 506 | Plovdiv | Bulgaria | ||
| 5 | Site 500 | Sofia | Bulgaria | ||
| 6 | Site 502 | Sofia | Bulgaria | ||
| 7 | Site 504 | Sofia | Bulgaria | ||
| 8 | Site 507 | Sofia | Bulgaria | ||
| 9 | Site 509 | Sofia | Bulgaria | ||
| 10 | Site 511 | Sofia | Bulgaria | ||
| 11 | Site 508 | Varna | Bulgaria | ||
| 12 | Site 510 | Varna | Bulgaria | ||
| 13 | Site 109 | Chrudim | Czech Republic | ||
| 14 | Site 117 | Havirov | Czech Republic | ||
| 15 | Site 101 | Olomouc | Czech Republic | ||
| 16 | Site 114 | Olomouc | Czech Republic | ||
| 17 | Site 116 | Ostrava | Czech Republic | ||
| 18 | Site 107 | Pardubice | Czech Republic | ||
| 19 | Site 111 | Pardubice | Czech Republic | ||
| 20 | Site 113 | Plzen | Czech Republic | ||
| 21 | Site 108 | Praha 1 | Czech Republic | ||
| 22 | Site 100 | Praha 2 | Czech Republic | ||
| 23 | Site 104 | Praha 5 | Czech Republic | ||
| 24 | Site 110 | Praha 6 | Czech Republic | ||
| 25 | Site 115 | Praha | Czech Republic | ||
| 26 | Site 103 | Teplice | Czech Republic | ||
| 27 | Site 106 | Trutnov | Czech Republic | ||
| 28 | Site 118 | Unicov | Czech Republic | ||
| 29 | Site 102 | Usti nad Orlici | Czech Republic | ||
| 30 | Site 203 | Berlin | Germany | ||
| 31 | Site 204 | Bochum | Germany | ||
| 32 | Site 205 | Dresden | Germany | ||
| 33 | Site 206 | Gorlitz | Germany | ||
| 34 | Site 202 | Hamburg | Germany | ||
| 35 | Site 208 | Karlsruhe | Germany | ||
| 36 | Site 207 | Leipzig | Germany | ||
| 37 | Site 201 | Magdeburg | Germany | ||
| 38 | Site 209 | Nuernberg | Germany | ||
| 39 | Site 200 | Unterschneidheim | Germany | ||
| 40 | Site 301 | Banska Bystrica | Slovakia | ||
| 41 | Site 307 | Bratislava | Slovakia | ||
| 42 | Site 310 | Bratislava | Slovakia | ||
| 43 | Site 311 | Bratislava | Slovakia | ||
| 44 | Site 312 | Bratislava | Slovakia | ||
| 45 | Site 309 | Dolny kubin | Slovakia | ||
| 46 | Site 302 | Kosice | Slovakia | ||
| 47 | Site 305 | Lucenec | Slovakia | ||
| 48 | Site 306 | Nitra | Slovakia | ||
| 49 | Site 304 | Nove Zamky | Slovakia | ||
| 50 | Site 308 | Presov | Slovakia | ||
| 51 | Site 303 | Vrable | Slovakia | ||
| 52 | Site 300 | Zilina | Slovakia | ||
| 53 | Site 416 | Donetsk | Ukraine | ||
| 54 | Site 401 | Kharkov | Ukraine | ||
| 55 | Site 412 | Kiev | Ukraine | ||
| 56 | Site 402 | Kyiv | Ukraine | ||
| 57 | Site 404 | Kyiv | Ukraine | ||
| 58 | Site 408 | Kyiv | Ukraine | ||
| 59 | Site 410 | Kyiv | Ukraine | ||
| 60 | Site 414 | Lutsk | Ukraine | ||
| 61 | Site 406 | Lviv | Ukraine | ||
| 62 | Site 407 | Odessa | Ukraine | ||
| 63 | Site 409 | Odessa | Ukraine | ||
| 64 | Site 411 | Odessa | Ukraine | ||
| 65 | Site 405 | Simferopol | Ukraine | ||
| 66 | Site 413 | Uzhorod | Ukraine | ||
| 67 | Site 400 | Vinnitsa | Ukraine | ||
| 68 | Site 415 | Zaporozhye | Ukraine |
Sponsors and Collaborators
- Solvay Pharmaceuticals
Investigators
- Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00362934
Other Study ID Numbers:
- C LF0242780-01 05 03
- 2006-000519-21
First Posted:
Aug 15, 2006
Last Update Posted:
Jul 8, 2009
Last Verified:
Jul 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: