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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00352183




Registration number
NCT00352183
Ethics application status
Date submitted
13/07/2006
Date registered
14/07/2006
Date last updated
8/07/2009

Titles & IDs
Public title
Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
Scientific 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.
Secondary ID [1] 0 0
ACTRN012605000777695
Secondary ID [2] 0 0
C LF0242780-01 05 02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fenofibrate/Simvastatin
Treatment: Drugs - Simvastatin

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40mg

Treatment: Drugs: Simvastatin
Simvastatin 40mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Triglycerides
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Percent change from baseline to 12 weeks of treatment in HDL-C
Timepoint [2] 0 0
12 weeks
Primary outcome [3] 0 0
Percent change from baseline to 12 weeks of treatment in LDL-C
Timepoint [3] 0 0
12 weeks
Secondary outcome [1] 0 0
Percent change from baseline to 24 weeks of treatment in Triglycerides
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Percent change from baseline to 24 weeks of treatment in HDL-C
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Percent change from baseline to 24 weeks of treatment in LDL-C
Timepoint [3] 0 0
24 weeks

Eligibility
Key inclusion criteria
* Mixed dyslipidemia
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
450
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site 204 - Adelaide
Recruitment hospital [2] 0 0
Site 214 - Adelaide
Recruitment hospital [3] 0 0
Site 203 - Bendigo
Recruitment hospital [4] 0 0
Site 207 - Brisbane
Recruitment hospital [5] 0 0
Site 208 - Brisbane
Recruitment hospital [6] 0 0
Site 221 - Brisbane
Recruitment hospital [7] 0 0
Site 202 - Burnie
Recruitment hospital [8] 0 0
Site 201 - Camperdown
Recruitment hospital [9] 0 0
Site 220 - Coffs Harbour
Recruitment hospital [10] 0 0
Site 218 - Daw Park
Recruitment hospital [11] 0 0
Site 212 - Elizabeth Vale
Recruitment hospital [12] 0 0
Site 217 - Fitzroy
Recruitment hospital [13] 0 0
Site 222 - Fremantle
Recruitment hospital [14] 0 0
Site 216 - Geelong
Recruitment hospital [15] 0 0
Site 225 - Ingleburn
Recruitment hospital [16] 0 0
Site 213 - Kippa-ring
Recruitment hospital [17] 0 0
Site 209 - Launceston
Recruitment hospital [18] 0 0
Site 219 - Liverpool
Recruitment hospital [19] 0 0
Site 223 - Malvern
Recruitment hospital [20] 0 0
Site 211 - Meadowbrook
Recruitment hospital [21] 0 0
Site 224 - Miranda
Recruitment hospital [22] 0 0
Site 210 - Nambour
Recruitment hospital [23] 0 0
Site 205 - Parkville
Recruitment hospital [24] 0 0
Site 206 - Sale
Recruitment hospital [25] 0 0
Site 215 - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bendigo
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Burnie
Recruitment postcode(s) [5] 0 0
- Camperdown
Recruitment postcode(s) [6] 0 0
- Coffs Harbour
Recruitment postcode(s) [7] 0 0
- Daw Park
Recruitment postcode(s) [8] 0 0
- Elizabeth Vale
Recruitment postcode(s) [9] 0 0
- Fitzroy
Recruitment postcode(s) [10] 0 0
- Fremantle
Recruitment postcode(s) [11] 0 0
- Geelong
Recruitment postcode(s) [12] 0 0
- Ingleburn
Recruitment postcode(s) [13] 0 0
- Kippa-ring
Recruitment postcode(s) [14] 0 0
- Launceston
Recruitment postcode(s) [15] 0 0
- Liverpool
Recruitment postcode(s) [16] 0 0
- Malvern
Recruitment postcode(s) [17] 0 0
- Meadowbrook
Recruitment postcode(s) [18] 0 0
- Miranda
Recruitment postcode(s) [19] 0 0
- Nambour
Recruitment postcode(s) [20] 0 0
- Parkville
Recruitment postcode(s) [21] 0 0
- Sale
Recruitment postcode(s) [22] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Estonia
State/province [1] 0 0
Tallinn
Country [2] 0 0
Estonia
State/province [2] 0 0
Tartu
Country [3] 0 0
Hungary
State/province [3] 0 0
Balatonfured
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Hungary
State/province [5] 0 0
Gyongyos
Country [6] 0 0
Hungary
State/province [6] 0 0
Gyor
Country [7] 0 0
Hungary
State/province [7] 0 0
Hodmezovasarhely
Country [8] 0 0
Hungary
State/province [8] 0 0
Kecskemet
Country [9] 0 0
Hungary
State/province [9] 0 0
Miskolc
Country [10] 0 0
Hungary
State/province [10] 0 0
Sopron
Country [11] 0 0
Hungary
State/province [11] 0 0
Szekesfehervar
Country [12] 0 0
Latvia
State/province [12] 0 0
Daugavpils
Country [13] 0 0
Latvia
State/province [13] 0 0
Jekabpils
Country [14] 0 0
Latvia
State/province [14] 0 0
Ogre
Country [15] 0 0
Latvia
State/province [15] 0 0
Riga
Country [16] 0 0
Latvia
State/province [16] 0 0
Tukums
Country [17] 0 0
Lithuania
State/province [17] 0 0
Alytus
Country [18] 0 0
Lithuania
State/province [18] 0 0
Kaunas
Country [19] 0 0
Lithuania
State/province [19] 0 0
Klaipeda
Country [20] 0 0
Lithuania
State/province [20] 0 0
Palanga
Country [21] 0 0
Lithuania
State/province [21] 0 0
Siauliai
Country [22] 0 0
Lithuania
State/province [22] 0 0
Vilnius
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland
Country [24] 0 0
New Zealand
State/province [24] 0 0
Blenheim
Country [25] 0 0
New Zealand
State/province [25] 0 0
Christchurch
Country [26] 0 0
New Zealand
State/province [26] 0 0
Dunedin
Country [27] 0 0
New Zealand
State/province [27] 0 0
Hamilton
Country [28] 0 0
New Zealand
State/province [28] 0 0
Hastings
Country [29] 0 0
New Zealand
State/province [29] 0 0
Nelson
Country [30] 0 0
New Zealand
State/province [30] 0 0
Newtown, Wellington
Country [31] 0 0
New Zealand
State/province [31] 0 0
Takapuna, Auckland
Country [32] 0 0
New Zealand
State/province [32] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Solvay Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
Trial website
https://clinicaltrials.gov/study/NCT00352183
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Director Solvay
Address 0 0
Solvay Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00352183