search
Back to results

Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fenofibrate/Simvastatin
Fenofibrate/Simvastatin
Pravastatin
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin, Hyperlipidemia Combined

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mixed dyslipidemia Exclusion Criteria: Known hypersensitivity to fenofibrates or simvastatin or pravastatin Pregnant or lactating women Contra-indication to fenofibrate or simvastatin or pravastatin Unstable or severe cardiac disease

Sites / Locations

  • Site 40
  • Site 39
  • Site 41
  • Site 37
  • Site 19
  • Site 22
  • Site 18
  • Site 38
  • Site 17
  • Site 21
  • Site 20
  • Site 24
  • Site 23
  • Site 5
  • Site 7
  • Site 1
  • Site 6
  • Site 4
  • Site 3
  • Site 2
  • Site 27
  • Site 31
  • Site 32
  • Site 25
  • Site 28
  • Site 26
  • Site 29
  • Site 30
  • Site 10
  • Site 9
  • Site 14
  • Site 35
  • Site 33
  • Site 34
  • Site 16
  • Site 13
  • Site 11
  • Site 12
  • Site 8
  • Site 36
  • Site 15

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline to 12 weeks of treatment in Triglycerides
Percent change from baseline to 12 weeks of treatment in HDL-C
Percent change from baseline to 12 weeks of treatment in LDL-C

Secondary Outcome Measures

Percent change from baseline to 12 weeks of treatment in Triglycerides
Percent change from baseline to 12 weeks of treatment in HDL-C
Percent change from baseline to 12 weeks of treatment in LDL-C

Full Information

First Posted
August 8, 2006
Last Updated
July 7, 2009
Sponsor
Solvay Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00362206
Brief Title
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
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 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin Alone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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 pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin, Hyperlipidemia Combined

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fenofibrate/Simvastatin
Intervention Description
Combination of Fenofibrate and Simvastatin 20mg
Intervention Type
Drug
Intervention Name(s)
Fenofibrate/Simvastatin
Intervention Description
Combination of Fenofibrate and Simvastatin 40 mg
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Intervention Description
Pravastatin 40 mg
Primary Outcome Measure Information:
Title
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time Frame
12 weeks
Title
Percent change from baseline to 12 weeks of treatment in HDL-C
Time Frame
12 weeks
Title
Percent change from baseline to 12 weeks of treatment in LDL-C
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time Frame
24 weeks
Title
Percent change from baseline to 12 weeks of treatment in HDL-C
Time Frame
24 weeks
Title
Percent change from baseline to 12 weeks of treatment in LDL-C
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mixed dyslipidemia Exclusion Criteria: Known hypersensitivity to fenofibrates or simvastatin or pravastatin Pregnant or lactating women Contra-indication to fenofibrate or simvastatin or pravastatin Unstable or severe cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 40
City
Athens
Country
Greece
Facility Name
Site 39
City
Ioannina
Country
Greece
Facility Name
Site 41
City
Thessaloniki
Country
Greece
Facility Name
Site 37
City
Beer Yaakov
Country
Israel
Facility Name
Site 19
City
Haifa
Country
Israel
Facility Name
Site 22
City
Holon
Country
Israel
Facility Name
Site 18
City
Jerusalem
Country
Israel
Facility Name
Site 38
City
Kfar Saba
Country
Israel
Facility Name
Site 17
City
Ramat Gan
Country
Israel
Facility Name
Site 21
City
Ramat Gan
Country
Israel
Facility Name
Site 20
City
Rechovot
Country
Israel
Facility Name
Site 24
City
Safed
Country
Israel
Facility Name
Site 23
City
Tel-Aviv
Country
Israel
Facility Name
Site 5
City
Arad
Country
Romania
Facility Name
Site 7
City
Bacau
Country
Romania
Facility Name
Site 1
City
Bucuresti
Country
Romania
Facility Name
Site 6
City
Cluj-Napoca
Country
Romania
Facility Name
Site 4
City
Oradea
Country
Romania
Facility Name
Site 3
City
Ploiesti
Country
Romania
Facility Name
Site 2
City
Targu Mures
Country
Romania
Facility Name
Site 27
City
Barnaul
Country
Russian Federation
Facility Name
Site 31
City
Kemerovo
Country
Russian Federation
Facility Name
Site 32
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Site 25
City
Moscow
Country
Russian Federation
Facility Name
Site 28
City
Novosibirsk
Country
Russian Federation
Facility Name
Site 26
City
Smolensk
Country
Russian Federation
Facility Name
Site 29
City
St. Petersburg
Country
Russian Federation
Facility Name
Site 30
City
Voronezh
Country
Russian Federation
Facility Name
Site 10
City
Alberton
Country
South Africa
Facility Name
Site 9
City
Bloemfontein
Country
South Africa
Facility Name
Site 14
City
Cape Town
Country
South Africa
Facility Name
Site 35
City
Durban
Country
South Africa
Facility Name
Site 33
City
Hillcrest
Country
South Africa
Facility Name
Site 34
City
Kempton Park
Country
South Africa
Facility Name
Site 16
City
Komatipoort
Country
South Africa
Facility Name
Site 13
City
Krugersdorp
Country
South Africa
Facility Name
Site 11
City
Parow
Country
South Africa
Facility Name
Site 12
City
Port Elizabeth
Country
South Africa
Facility Name
Site 8
City
Pretoria
Country
South Africa
Facility Name
Site 36
City
Umkomaas
Country
South Africa
Facility Name
Site 15
City
Worcester
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

We'll reach out to this number within 24 hrs