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

NCT01674712 | Completed Phase 3 Results

• 2 other identifiers: M13-3772011-005924-16
• Study Type: interventional
• Target: 575
• Locations: 7 countries
• Sites: 69

Brief Summary

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.

Conditions

Dyslipidemia

Keywords

Fibrates; Dyslipidemia

Outcome Measures

Primary Outcomes (3)

• Percentage of Change of TG (Triglyceride)

  Collection and measurement of blood samples.

  from baseline to 12 weeks of treatment

• Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)

  Collection and measurement of blood samples.

  from baseline to 12 weeks of treatment

• Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)

  Collection and measurement of blood samples.

  from baseline to 12 weeks of treatment

Secondary Outcomes (12)

• Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline

  12 weeks

• Percentage of TC (Triglyceride) From Baseline

  12 weeks

• Percentage of Apolipoprotein AI From Baseline

  12 weeks

• Percentage of Apolipoprotein B From Baseline

  12 weeks

• Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline

  12 weeks

Study Arms (5)

Fenofibrate/simvastatin 145/20 mg

EXPERIMENTAL

Drug: Fixed Combination of Fenofibrate/simvastatin 145/20 mg

Simvastatin 20 mg

ACTIVE COMPARATOR

Drug: Simvastatin 20 mg

Fenofibrate 145 mg

ACTIVE COMPARATOR

Drug: Fenofibrate 145 mg

Fenofibrate/simvastatin 145/40 mg

EXPERIMENTAL

Drug: Fixed Combination of Fenofibrate/simvastatin 145/40 mg

Simvastatin 40 mg

ACTIVE COMPARATOR

Drug: Simvastatin 40 mg

Interventions

Fixed Combination of Fenofibrate/simvastatin 145/20 mg DRUG

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

Fenofibrate/simvastatin 145/20 mg

Simvastatin 20 mg DRUG

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

Simvastatin 20 mg

Fenofibrate 145 mg DRUG

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

Fenofibrate 145 mg

Fixed Combination of Fenofibrate/simvastatin 145/40 mg DRUG

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

Fenofibrate/simvastatin 145/40 mg

Simvastatin 40 mg DRUG

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

Simvastatin 40 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• between 18 (inclusive) and 80 years
• 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)
• 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
• Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)

You may not qualify if:

• 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,
• Pregnant or lactating women,
• Unable or unwilling to comply with the protocol and the recommended diet,
• Likely to withdraw from the study before its completion,

Sponsors & Collaborators

• Abbott: lead

Study Sites (69)

Site Reference ID/Investigator# 77961

Buenos Aires, 7600, Argentina

Location

Site Reference ID/Investigator# 77957

Buenos Aires, B1605DSX, Argentina

Location

Site Reference ID/Investigator# 77958

Buenos Aires, B1657BHD, Argentina

Location

Site Reference ID/Investigator# 77960

Buenos Aires, B1722COV, Argentina

Location

Site Reference ID/Investigator# 77959

Buenos Aires, B1878GEG, Argentina

Location

Site Reference ID/Investigator# 77969

Buenos Aires, B2800DGH, Argentina

Location

Site Reference ID/Investigator# 77967

Buenos Aires, C1179AAB, Argentina

Location

Site Reference ID/Investigator# 77968

Buenos Aires, C1181ACK, Argentina

Location

Site Reference ID/Investigator# 77965

Buenos Aires, C1405BCH, Argentina

Location

Site Reference ID/Investigator# 77956

Buenos Aires, Argentina

Location

Site Reference ID/Investigator# 77966

Cipolletti - Rio Negro, 8324, Argentina

Location

Site Reference ID/Investigator# 77963

San Miguel de Tucumán, 4000JCU, Argentina

Location

Site Reference ID/Investigator# 77955

Santa Fe, 3000, Argentina

Location

Site Reference ID/Investigator# 77962

Santa Fe, 3000, Argentina

Location

Site Reference ID/Investigator# 77964

Santa Fe, S2000DSV, Argentina

Location

Site reference ID/Investigator # 99617

Benátky nad Jizerou, 294 71, Czechia

Location

Site Reference ID/Investigator# 80097

Brno, 656 91, Czechia

Location

Site reference ID/Investigator # 102335

Brno, 65691, Czechia

Location

Site Reference ID/Investigator# 80094

Prague, 108 00, Czechia

Location

Site Reference ID/Investigator# 80095

Prague, 14059, Czechia

Location

Site Reference ID/Investigator# 80093

Prague, 18081, Czechia

Location

Site Reference ID/Investigator# 80098

Teplice, 415 01, Czechia

Location

Site Reference ID/Investigator# 80096

Ústí nad Labem, 40113, Czechia

Location

Site Reference ID/Investigator# 80099

Znojmo, 669 02, Czechia

Location

Site reference ID/Investigator # 97356

Berlin, 10117, Germany

Location

Site Reference ID/Investigator# 90673

Berlin, 10249, Germany

Location

Site Reference ID/Investigator# 80100

Berlin, 12351, Germany

Location

Site reference ID/Investigator # 97357

Berlin, 13125, Germany

Location

Site reference ID/Investigator # 102016

Cologne, 51069, Germany

Location

Site reference ID/Investigator # 102017

Dortmund, 44137, Germany

Location

Site reference ID/Investigator # 99876

Dresden, 01069, Germany

Location

Site Reference ID/Investigator# 80102

Düsseldorf, 40597, Germany

Location

Site Reference ID/Investigator# 80104

Essen, 45355, Germany

Location

Site Reference ID/Investigator# 80103

Essen, 45359, Germany

Location

Site Reference ID/Investigator# 80105

Frankfurt, 60594, Germany

Location

Site Reference ID/Investigator# 80101

Goch, 47574, Germany

Location

Site reference ID/Investigator # 99902

Hamburg, 20253, Germany

Location

Site reference ID/Investigator # 102015

Karlsruhe, 76199, Germany

Location

Site Reference ID/Investigator# 77970

Guadalajara, Jal., C.P. 44130, Mexico

Location

Site Reference ID/Investigator# 77973

Mexico City, C.P. 06600, Mexico

Location

Site Reference ID/Investigator# 77972

Mexico City, C.P. 11850, Mexico

Location

Site Reference ID/Investigator# 77974

Zapopan, 45200, Mexico

Location

Site Reference ID/Investigator# 80111

Gdansk, 80-952, Poland

Location

Site Reference ID/Investigator# 80112

Gdansk, 80-952, Poland

Location

Site Reference ID/Investigator# 80110

Gdynia, 81-423, Poland

Location

Site Reference ID/Investigator# 80106

Katowice, 40-954, Poland

Location

Site Reference ID/Investigator# 80109

Płock, 09-400, Poland

Location

Site Reference ID/Investigator# 80108

Skierniewice, 96-100, Poland

Location

Site Reference ID/Investigator# 80107

Warsaw, 01-868, Poland

Location

Site reference ID/Investigator # 80115

Bucharest, 10242, Romania

Location

Site Reference ID/Investigator# 80114

Bucharest, 11172, Romania

Location

Site Reference ID/Investigator# 80117

Bucharest, 11794, Romania

Location

Site Reference ID/Investigator# 80116

Bucharest, 20054, Romania

Location

Site Reference ID/Investigator# 80119

Bucharest, 22328, Romania

Location

Site Reference ID/Investigator# 80113

Bucharest, 42122, Romania

Location

Site Reference ID/Investigator# 80118

Iași, 700547, Romania

Location

Site Reference ID/Investigator# 80120

Kemerovo, 650002, Russia

Location

Site Reference ID/Investigator# 80135

Moscow, 119435, Russia

Location

Site Reference ID/Investigator# 80137

Moscow, 119620, Russia

Location

Site Reference ID/Investigator# 80124

Moscow, 119991, Russia

Location

Site Reference ID/Investigator# 80127

Moscow, 125284, Russia

Location

Site Reference ID/Investigator# 80122

Novosibirsk, 630008, Russia

Location

Site Reference ID/Investigator# 80121

Novosibirsk, 630047, Russia

Location

Site Reference ID/Investigator# 80133

Novosibirsk, 630068, Russia

Location

Site reference ID/Investigator # 80134

Saint Petersburg, 194156, Russia

Location

Site reference ID/Investigator # 80126

Saint Petersburg, 197022, Russia

Location

Site reference ID/Investigator # 80128

Saint Petersburg, 197022, Russia

Location

Site Reference ID/Investigator# 80136

Saint Petersburg, 199106, Russia

Location

Site Reference ID/Investigator# 80125

Yaroslavl, 150010, Russia

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Simvastatin; Fenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Phenols; Ketones

Results Point of Contact

• Title: Associate Director Clinical Services
• Organization: Abbott

taco.baardman@abbott.com

Study Officials

• Jean-Claude Ansquer, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: August 29, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 11, 2014
• Results First Posted: October 30, 2014

Record last verified: 2014-11

Locations

RU (13); ME (4); AR (15); DE (14); RO (7); CZ (9); PL (7)