Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00352183

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Diseases	Drug: Fenofibrate/Simvastatin Drug: Simvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Drug Information available for: Procetofen Simvastatin

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline to 24 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Percent change from baseline to 24 weeks of treatment in LDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	450
Study Start Date:	January 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Fenofibrate/Simvastatin Combination of Fenofibrate and Simvastatin 40mg
2: Active Comparator	Drug: Simvastatin Simvastatin 40mg

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352183

Hide Study Locations

Locations

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

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Martine Guy )
Study ID Numbers:	C LF0242780-01 05 02, ACTRN012605000777695
Study First Received:	July 13, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00352183 History of Changes
Health Authority:	New Zealand: Health Research Council; Australia: Department of Health and Ageing Therapeutic Goods Administration; Estonia: The State Agency of Medicine; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Hyperlipidemia Combined
Combination of fenofibrate and simvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Simvastatin
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009