MedDataX Logo

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

NCT ID: NCT01674712

Last Updated: 2014-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

575 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fibrates Dyslipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fenofibrate/simvastatin 145/20 mg

Group Type EXPERIMENTAL

Fixed Combination of Fenofibrate/simvastatin 145/20 mg

Intervention Type DRUG

Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks

Simvastatin 20 mg

Group Type ACTIVE_COMPARATOR

Simvastatin 20 mg

Intervention Type DRUG

Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks

Fenofibrate 145 mg

Group Type ACTIVE_COMPARATOR

Fenofibrate 145 mg

Intervention Type DRUG

Fenofibrate, tablet, 145 mg, once daily, 12 weeks

Fenofibrate/simvastatin 145/40 mg

Group Type EXPERIMENTAL

Fixed Combination of Fenofibrate/simvastatin 145/40 mg

Intervention Type DRUG

Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks

Simvastatin 40 mg

Group Type ACTIVE_COMPARATOR

Simvastatin 40 mg

Intervention Type DRUG

simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fixed Combination of Fenofibrate/simvastatin 145/20 mg

Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks

Intervention Type DRUG

Simvastatin 20 mg

Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks

Intervention Type DRUG

Fenofibrate 145 mg

Fenofibrate, tablet, 145 mg, once daily, 12 weeks

Intervention Type DRUG

Fixed Combination of Fenofibrate/simvastatin 145/40 mg

Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks

Intervention Type DRUG

Simvastatin 40 mg

simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Claude Ansquer, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 77961

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77957

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77958

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77960

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77959

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77969

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77967

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77968

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77965

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77956

Buenos Aires, , Argentina

Site Status

Site Reference ID/Investigator# 77966

Cipolletti - Rio Negro, , Argentina

Site Status

Site Reference ID/Investigator# 77963

San Miguel de Tucumán, , Argentina

Site Status

Site Reference ID/Investigator# 77955

Santa Fe, , Argentina

Site Status

Site Reference ID/Investigator# 77962

Santa Fe, , Argentina

Site Status

Site Reference ID/Investigator# 77964

Santa Fe, , Argentina

Site Status

Site reference ID/Investigator # 99617

Benátky nad Jizerou, , Czechia

Site Status

Site Reference ID/Investigator# 80097

Brno, , Czechia

Site Status

Site reference ID/Investigator # 102335

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 80094

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 80095

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 80093

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 80098

Teplice, , Czechia

Site Status

Site Reference ID/Investigator# 80096

Ústí nad Labem, , Czechia

Site Status

Site Reference ID/Investigator# 80099

Znojmo, , Czechia

Site Status

Site reference ID/Investigator # 97356

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 90673

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 80100

Berlin, , Germany

Site Status

Site reference ID/Investigator # 97357

Berlin, , Germany

Site Status

Site reference ID/Investigator # 102016

Cologne, , Germany

Site Status

Site reference ID/Investigator # 102017

Dortmund, , Germany

Site Status

Site reference ID/Investigator # 99876

Dresden, , Germany

Site Status

Site Reference ID/Investigator# 80102

Düsseldorf, , Germany

Site Status

Site Reference ID/Investigator# 80104

Essen, , Germany

Site Status

Site Reference ID/Investigator# 80103

Essen, , Germany

Site Status

Site Reference ID/Investigator# 80105

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 80101

Goch, , Germany

Site Status

Site reference ID/Investigator # 99902

Hamburg, , Germany

Site Status

Site reference ID/Investigator # 102015

Karlsruhe, , Germany

Site Status

Site Reference ID/Investigator# 77970

Guadalajara, Jal., , Mexico

Site Status

Site Reference ID/Investigator# 77973

Mexico City, , Mexico

Site Status

Site Reference ID/Investigator# 77972

Mexico City, , Mexico

Site Status

Site Reference ID/Investigator# 77974

Zapopan, , Mexico

Site Status

Site Reference ID/Investigator# 80111

Gdansk, , Poland

Site Status

Site Reference ID/Investigator# 80112

Gdansk, , Poland

Site Status

Site Reference ID/Investigator# 80110

Gdynia, , Poland

Site Status

Site Reference ID/Investigator# 80106

Katowice, , Poland

Site Status

Site Reference ID/Investigator# 80109

Płock, , Poland

Site Status

Site Reference ID/Investigator# 80108

Skierniewice, , Poland

Site Status

Site Reference ID/Investigator# 80107

Warsaw, , Poland

Site Status

Site reference ID/Investigator # 80115

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 80114

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 80117

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 80116

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 80119

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 80113

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 80118

Iași, , Romania

Site Status

Site Reference ID/Investigator# 80120

Kemerovo, , Russia

Site Status

Site Reference ID/Investigator# 80135

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 80137

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 80124

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 80127

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 80122

Novosibirsk, , Russia

Site Status

Site Reference ID/Investigator# 80121

Novosibirsk, , Russia

Site Status

Site Reference ID/Investigator# 80133

Novosibirsk, , Russia

Site Status

Site reference ID/Investigator # 80134

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator # 80126

Saint Petersburg, , Russia

Site Status

Site reference ID/Investigator # 80128

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 80136

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 80125

Yaroslavl, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina Czechia Germany Mexico Poland Romania Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-005924-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-377

Identifier Type: -

Identifier Source: org_study_id