Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Cardiovascular Diseases Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin Alone.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352183
• Other study ID #: C LF0242780-01 05 02
• Secondary ID: ACTRN01260500077
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2006
• Last updated: July 7, 2009
• Start date: January 2006
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health Research CouncilAustralia: Department of Health and Ageing Therapeutic Goods AdministrationEstonia: The State Agency of MedicineHungary: National Institute of PharmacyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Mixed dyslipidemia

Exclusion Criteria:

• Diabetes,

• Known hypersensitivity to fenofibrate or simvastatin,

• Pregnant or lactating women,

• Contra-indication to fenofibrate or simvastatin,

• Unstable or severe cardiac disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40mg
• Simvastatin
Simvastatin 40mg

Locations

Country	Name	City	State
Australia	Site 204	Adelaide
Australia	Site 214	Adelaide
Australia	Site 203	Bendigo
Australia	Site 207	Brisbane
Australia	Site 208	Brisbane
Australia	Site 221	Brisbane
Australia	Site 202	Burnie
Australia	Site 201	Camperdown
Australia	Site 220	Coffs Harbour
Australia	Site 218	Daw Park
Australia	Site 212	Elizabeth Vale
Australia	Site 217	Fitzroy
Australia	Site 222	Fremantle
Australia	Site 216	Geelong
Australia	Site 225	Ingleburn
Australia	Site 213	Kippa-ring
Australia	Site 209	Launceston
Australia	Site 219	Liverpool
Australia	Site 223	Malvern
Australia	Site 211	Meadowbrook
Australia	Site 224	Miranda
Australia	Site 210	Nambour
Australia	Site 205	Parkville
Australia	Site 206	Sale
Australia	Site 215	Sydney
Estonia	Site 301	Tallinn
Estonia	Site 302	Tallinn
Estonia	Site 303	Tallinn
Estonia	Site 305	Tallinn
Estonia	Site 306	Tallinn
Estonia	Site 304	Tartu
Estonia	Site 307	Tartu
Hungary	Site 603	Balatonfured
Hungary	Site 605	Budapest
Hungary	Site 608	Budapest
Hungary	Site 604	Gyongyos
Hungary	Site 602	Gyor
Hungary	Site 610	Hodmezovasarhely
Hungary	Site 609	Kecskemet
Hungary	Site 601	Miskolc
Hungary	Site 607	Sopron
Hungary	Site 606	Szekesfehervar
Latvia	Site 403	Daugavpils
Latvia	Site 406	Jekabpils
Latvia	Site 401	Ogre
Latvia	Site 402	Riga
Latvia	Site 405	Riga
Latvia	Site 404	Tukums
Lithuania	Site 502	Alytus
Lithuania	Site 503	Kaunas
Lithuania	Site 506	Kaunas
Lithuania	Site 505	Klaipeda
Lithuania	Site 507	Klaipeda
Lithuania	Site 508	Palanga
Lithuania	Site 504	Siauliai
Lithuania	Site 501	Vilnius
New Zealand	Site 102	Auckland
New Zealand	Site 103	Auckland
New Zealand	Site 107	Blenheim
New Zealand	Site 101	Christchurch
New Zealand	Site 108	Dunedin
New Zealand	Site 104	Hamilton
New Zealand	Site 111	Hastings
New Zealand	Site 106	Nelson
New Zealand	Site 110	Newtown, Wellington
New Zealand	Site 109	Takapuna, Auckland
New Zealand	Site 105	Tauranga

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Estonia,  Hungary,  Latvia,  Lithuania,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglycerides		12 weeks	No
Primary	Percent change from baseline to 12 weeks of treatment in HDL-C		12 weeks	No
Primary	Percent change from baseline to 12 weeks of treatment in LDL-C		12 weeks	No
Secondary	Percent change from baseline to 24 weeks of treatment in Triglycerides		24 weeks	No
Secondary	Percent change from baseline to 24 weeks of treatment in HDL-C		24 weeks	No
Secondary	Percent change from baseline to 24 weeks of treatment in LDL-C		24 weeks	No