A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease

November 24, 2014 updated by: Abbott

A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate / Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.

This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has been marketed in more than 80 countries since 1975. Simvastatin is also used for the treatment of patients with a high level of cholesterol. These have also been marketed worldwide for more than 20 years. It is important to treat high levels of fats in the blood because it has been shown that even mildly elevated level of lipids in the blood can lead to diseases of the blood vessels. It has been shown in several studies and in clinical practice that the combination of fenofibrate plus simvastatin can lead to improved effects on blood fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

575

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 7600
        • Site Reference ID/Investigator# 77961
      • Buenos Aires, Argentina, B1605DSX
        • Site Reference ID/Investigator# 77957
      • Buenos Aires, Argentina, B1657BHD
        • Site Reference ID/Investigator# 77958
      • Buenos Aires, Argentina, B1722COV
        • Site Reference ID/Investigator# 77960
      • Buenos Aires, Argentina, B1878GEG
        • Site Reference ID/Investigator# 77959
      • Buenos Aires, Argentina, B2800DGH
        • Site Reference ID/Investigator# 77969
      • Buenos Aires, Argentina, C1179AAB
        • Site Reference ID/Investigator# 77967
      • Buenos Aires, Argentina, C1181ACK
        • Site Reference ID/Investigator# 77968
      • Buenos Aires, Argentina, C1405BCH
        • Site Reference ID/Investigator# 77965
      • Buenos Aires, Argentina
        • Site Reference ID/Investigator# 77956
      • Cipolletti - Rio Negro, Argentina, 8324
        • Site Reference ID/Investigator# 77966
      • Santa Fe, Argentina, 3000
        • Site Reference ID/Investigator# 77955
      • Santa Fe, Argentina, 3000
        • Site Reference ID/Investigator# 77962
      • Santa Fe, Argentina, S2000DSV
        • Site Reference ID/Investigator# 77964
      • Tucuman, Argentina, 4000JCU
        • Site Reference ID/Investigator# 77963
  • Czech Republic
      • Benatky nad Jizerou, Czech Republic, 294 71
        • Site reference ID/Investigator # 99617
      • Brno, Czech Republic, 656 91
        • Site Reference ID/Investigator# 80097
      • Brno, Czech Republic, 65691
        • Site reference ID/Investigator # 102335
      • Prague 10, Czech Republic, 108 00
        • Site Reference ID/Investigator# 80094
      • Prague 4, Czech Republic, 14059
        • Site Reference ID/Investigator# 80095
      • Praha 8, Czech Republic, 18081
        • Site Reference ID/Investigator# 80093
      • Teplice, Czech Republic, 415 01
        • Site Reference ID/Investigator# 80098
      • Usti nad Labem, Czech Republic, 40113
        • Site Reference ID/Investigator# 80096
      • Znojmo, Czech Republic, 669 02
        • Site Reference ID/Investigator# 80099
  • Germany
      • Berlin, Germany, 10117
        • Site reference ID/Investigator # 97356
      • Berlin, Germany, 10249
        • Site Reference ID/Investigator# 90673
      • Berlin, Germany, 12351
        • Site Reference ID/Investigator# 80100
      • Berlin, Germany, 13125
        • Site reference ID/Investigator # 97357
      • Dortmund, Germany, 44137
        • Site reference ID/Investigator # 102017
      • Dresden, Germany, 01069
        • Site reference ID/Investigator # 99876
      • Dusseldorf, Germany, 40597
        • Site Reference ID/Investigator# 80102
      • Essen, Germany, 45355
        • Site Reference ID/Investigator# 80104
      • Essen, Germany, 45359
        • Site Reference ID/Investigator# 80103
      • Frankfurt, Germany, 60594
        • Site Reference ID/Investigator# 80105
      • Goch, Germany, 47574
        • Site Reference ID/Investigator# 80101
      • Hamburg, Germany, 20253
        • Site reference ID/Investigator # 99902
      • Karlsruhe, Germany, 76199
        • Site reference ID/Investigator # 102015
      • Koeln, Germany, 51069
        • Site reference ID/Investigator # 102016
  • Mexico
      • Guadalajara, Jal., Mexico, C.P. 44130
        • Site Reference ID/Investigator# 77970
      • Mexico D.F., Mexico, C.P. 06600
        • Site Reference ID/Investigator# 77973
      • Mexico D.F., Mexico, C.P. 11850
        • Site Reference ID/Investigator# 77972
      • Zapopan, Mexico, 45200
        • Site Reference ID/Investigator# 77974
  • Poland
      • Gdansk, Poland, 80-952
        • Site Reference ID/Investigator# 80111
      • Gdansk, Poland, 80-952
        • Site Reference ID/Investigator# 80112
      • Gdynia, Poland, 81-423
        • Site Reference ID/Investigator# 80110
      • Katowice, Poland, 40-954
        • Site Reference ID/Investigator# 80106
      • Plock, Poland, 09-400
        • Site Reference ID/Investigator# 80109
      • Skierniewice, Poland, 96-100
        • Site Reference ID/Investigator# 80108
      • Warsaw, Poland, 01-868
        • Site Reference ID/Investigator# 80107
  • Romania
      • Bucharest, Romania, 10242
        • Site reference ID/Investigator # 80115
      • Bucharest, Romania, 11172
        • Site Reference ID/Investigator# 80114
      • Bucharest, Romania, 11794
        • Site Reference ID/Investigator# 80117
      • Bucharest, Romania, 20054
        • Site Reference ID/Investigator# 80116
      • Bucharest, Romania, 22328
        • Site Reference ID/Investigator# 80119
      • Bucharest, Romania, 42122
        • Site Reference ID/Investigator# 80113
      • Iasi, Romania, 700547
        • Site Reference ID/Investigator# 80118
  • Russian Federation
      • Kemerovo, Russian Federation, 650002
        • Site Reference ID/Investigator# 80120
      • Moscow, Russian Federation, 119435
        • Site Reference ID/Investigator# 80135
      • Moscow, Russian Federation, 119620
        • Site Reference ID/Investigator# 80137
      • Moscow, Russian Federation, 119991
        • Site Reference ID/Investigator# 80124
      • Moscow, Russian Federation, 125284
        • Site Reference ID/Investigator# 80127
      • Novosibirsk, Russian Federation, 630008
        • Site Reference ID/Investigator# 80122
      • Novosibirsk, Russian Federation, 630047
        • Site Reference ID/Investigator# 80121
      • Novosibirsk, Russian Federation, 630068
        • Site Reference ID/Investigator# 80133
      • St. Petersburg, Russian Federation, 194156
        • Site reference ID/Investigator # 80134
      • St. Petersburg, Russian Federation, 197022
        • Site reference ID/Investigator # 80126
      • St. Petersburg, Russian Federation, 197022
        • Site reference ID/Investigator # 80128
      • St. Petersburg, Russian Federation, 199106
        • Site Reference ID/Investigator# 80136
      • Yaroslavl, Russian Federation, 150010
        • Site Reference ID/Investigator# 80125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
  2. between 18 (inclusive) and 80 years

  3. With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):

    • TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and
    • LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)
  4. High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent
  5. Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)

Exclusion Criteria:

  1. Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
  2. Pregnant or lactating women,
  3. Unable or unwilling to comply with the protocol and the recommended diet,
  4. Likely to withdraw from the study before its completion,
  5. Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simvastatin 40 mg
Drug: Simvastatin 40 mg
simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
Experimental: Fenofibrate/simvastatin 145/20 mg
Drug: Fixed Combination of Fenofibrate/simvastatin 145/20 mg
Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
Active Comparator: Simvastatin 20 mg
Drug: Simvastatin 20 mg
Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Active Comparator: Fenofibrate 145 mg
Drug: Fenofibrate 145 mg
Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Experimental: Fenofibrate/simvastatin 145/40 mg
Drug: Fixed Combination of Fenofibrate/simvastatin 145/40 mg
Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Change of TG (Triglyceride)
Time Frame: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
from baseline to 12 weeks of treatment
Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
Time Frame: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
from baseline to 12 weeks of treatment
Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
Time Frame: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
from baseline to 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Percentage of TC (Triglyceride) From Baseline
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Percentage of Apolipoprotein AI From Baseline
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Percentage of Apolipoprotein B From Baseline
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Adverse Events
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Creatine Kinase (CK)
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Alanine Aminotransferase (ALT)
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Plasma Creatinine
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Total Bilirubin
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks
Cystatin C
Time Frame: 12 weeks
Collection and measurement of blood samples
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Jean-Claude Ansquer, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-377
  • 2011-005924-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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