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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

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fixed Combination of Fenofibrate/simvastatin 145/20 mg

Simvastatin 20 mg

Fenofibrate 145 mg

Fixed Combination of Fenofibrate/simvastatin 145/40 mg

Simvastatin 40 mg

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Fibrates, Dyslipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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)
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)

Exclusion Criteria:

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,
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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Fenofibrate/simvastatin 145/20 mg

Simvastatin 20 mg

Fenofibrate 145 mg

Fenofibrate/simvastatin 145/40 mg

Simvastatin 40 mg

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Change of TG (Triglyceride)

Collection and measurement of blood samples.

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

Collection and measurement of blood samples.

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

Collection and measurement of blood samples.

Secondary Outcome Measures

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

Collection and measurement of blood samples

Percentage of TC (Triglyceride) From Baseline

Collection and measurement of blood samples

Percentage of Apolipoprotein AI From Baseline

Collection and measurement of blood samples

Percentage of Apolipoprotein B From Baseline

Collection and measurement of blood samples

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

Collection and measurement of blood samples

Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)

Collection and measurement of blood samples

Adverse Events

Collection and measurement of blood samples

Creatine Kinase (CK)

Collection and measurement of blood samples

Alanine Aminotransferase (ALT)

Collection and measurement of blood samples

Plasma Creatinine

Collection and measurement of blood samples

Total Bilirubin

Collection and measurement of blood samples

Cystatin C

Collection and measurement of blood samples

Full Information

NCT ID

NCT01674712

First Posted

June 26, 2012

Last Updated

November 24, 2014

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT01674712

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

Fibrates, Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

575 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fenofibrate/simvastatin 145/20 mg

Arm Type

Experimental

Arm Title

Simvastatin 20 mg

Arm Type

Active Comparator

Arm Title

Fenofibrate 145 mg

Arm Type

Active Comparator

Arm Title

Fenofibrate/simvastatin 145/40 mg

Arm Type

Experimental

Arm Title

Simvastatin 40 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Fixed Combination of Fenofibrate/simvastatin 145/20 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Simvastatin 20 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fenofibrate 145 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fixed Combination of Fenofibrate/simvastatin 145/40 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Simvastatin 40 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Change of TG (Triglyceride)

Description

Collection and measurement of blood samples.

Time Frame

from baseline to 12 weeks of treatment

Title

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

Description

Collection and measurement of blood samples.

Time Frame

from baseline to 12 weeks of treatment

Title

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

Description

Collection and measurement of blood samples.

Time Frame

from baseline to 12 weeks of treatment

Secondary Outcome Measure Information:

Title

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

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Percentage of TC (Triglyceride) From Baseline

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Percentage of Apolipoprotein AI From Baseline

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Percentage of Apolipoprotein B From Baseline

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

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

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Adverse Events

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Creatine Kinase (CK)

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Alanine Aminotransferase (ALT)

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Plasma Creatinine

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Total Bilirubin

Description

Collection and measurement of blood samples

Time Frame

12 weeks

Title

Cystatin C

Description

Collection and measurement of blood samples

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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) 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) Exclusion Criteria: 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, 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Claude Ansquer, MD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 77961

City

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77957

City

Buenos Aires

ZIP/Postal Code

B1605DSX

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77958

City

Buenos Aires

ZIP/Postal Code

B1657BHD

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77960

City

Buenos Aires

ZIP/Postal Code

B1722COV

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77959

City

Buenos Aires

ZIP/Postal Code

B1878GEG

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77969

City

Buenos Aires

ZIP/Postal Code

B2800DGH

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77967

City

Buenos Aires

ZIP/Postal Code

C1179AAB

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77968

City

Buenos Aires

ZIP/Postal Code

C1181ACK

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77965

City

Buenos Aires

ZIP/Postal Code

C1405BCH

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77956

City

Buenos Aires

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77966

City

Cipolletti - Rio Negro

ZIP/Postal Code

8324

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77955

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77962

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77964

City

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

Site Reference ID/Investigator# 77963

City

Tucuman

ZIP/Postal Code

4000JCU

Country

Argentina

Facility Name

Site reference ID/Investigator # 99617

City

Benatky nad Jizerou

ZIP/Postal Code

294 71

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 80097

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

Site reference ID/Investigator # 102335

City

Brno

ZIP/Postal Code

65691

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 80094

City

Prague 10

ZIP/Postal Code

108 00

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 80095

City

Prague 4

ZIP/Postal Code

14059

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 80093

City

Praha 8

ZIP/Postal Code

18081

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 80098

City

Teplice

ZIP/Postal Code

415 01

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 80096

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 80099

City

Znojmo

ZIP/Postal Code

669 02

Country

Czech Republic

Facility Name

Site reference ID/Investigator # 97356

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Site Reference ID/Investigator# 90673

City

Berlin

ZIP/Postal Code

10249

Country

Germany

Facility Name

Site Reference ID/Investigator# 80100

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Site reference ID/Investigator # 97357

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Site reference ID/Investigator # 102017

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Site reference ID/Investigator # 99876

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Site Reference ID/Investigator# 80102

City

Dusseldorf

ZIP/Postal Code

40597

Country

Germany

Facility Name

Site Reference ID/Investigator# 80104

City

Essen

ZIP/Postal Code

45355

Country

Germany

Facility Name

Site Reference ID/Investigator# 80103

City

Essen

ZIP/Postal Code

45359

Country

Germany

Facility Name

Site Reference ID/Investigator# 80105

City

Frankfurt

ZIP/Postal Code

60594

Country

Germany

Facility Name

Site Reference ID/Investigator# 80101

City

Goch

ZIP/Postal Code

47574

Country

Germany

Facility Name

Site reference ID/Investigator # 99902

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Site reference ID/Investigator # 102015

City

Karlsruhe

ZIP/Postal Code

76199

Country

Germany

Facility Name

Site reference ID/Investigator # 102016

City

Koeln

ZIP/Postal Code

51069

Country

Germany

Facility Name

Site Reference ID/Investigator# 77970

City

Guadalajara, Jal.

ZIP/Postal Code

C.P. 44130

Country

Mexico

Facility Name

Site Reference ID/Investigator# 77973

City

Mexico D.F.

ZIP/Postal Code

C.P. 06600

Country

Mexico

Facility Name

Site Reference ID/Investigator# 77972

City

Mexico D.F.

ZIP/Postal Code

C.P. 11850

Country

Mexico

Facility Name

Site Reference ID/Investigator# 77974

City

Zapopan

ZIP/Postal Code

45200

Country

Mexico

Facility Name

Site Reference ID/Investigator# 80111

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Site Reference ID/Investigator# 80112

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Site Reference ID/Investigator# 80110

City

Gdynia

ZIP/Postal Code

81-423

Country

Poland

Facility Name

Site Reference ID/Investigator# 80106

City

Katowice

ZIP/Postal Code

40-954

Country

Poland

Facility Name

Site Reference ID/Investigator# 80109

City

Plock

ZIP/Postal Code

09-400

Country

Poland

Facility Name

Site Reference ID/Investigator# 80108

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Site Reference ID/Investigator# 80107

City

Warsaw

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Site reference ID/Investigator # 80115

City

Bucharest

ZIP/Postal Code

10242

Country

Romania

Facility Name

Site Reference ID/Investigator# 80114

City

Bucharest

ZIP/Postal Code

11172

Country

Romania

Facility Name

Site Reference ID/Investigator# 80117

City

Bucharest

ZIP/Postal Code

11794

Country

Romania

Facility Name

Site Reference ID/Investigator# 80116

City

Bucharest

ZIP/Postal Code

20054

Country

Romania

Facility Name

Site Reference ID/Investigator# 80119

City

Bucharest

ZIP/Postal Code

22328

Country

Romania

Facility Name

Site Reference ID/Investigator# 80113

City

Bucharest

ZIP/Postal Code

42122

Country

Romania

Facility Name

Site Reference ID/Investigator# 80118

City

Iasi

ZIP/Postal Code

700547

Country

Romania

Facility Name

Site Reference ID/Investigator# 80120

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80135

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80137

City

Moscow

ZIP/Postal Code

119620

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80124

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80127

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80122

City

Novosibirsk

ZIP/Postal Code

630008

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80121

City

Novosibirsk

ZIP/Postal Code

630047

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80133

City

Novosibirsk

ZIP/Postal Code

630068

Country

Russian Federation

Facility Name

Site reference ID/Investigator # 80134

City

St. Petersburg

ZIP/Postal Code

194156

Country

Russian Federation

Facility Name

Site reference ID/Investigator # 80126

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Site reference ID/Investigator # 80128

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80136

City

St. Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Site Reference ID/Investigator# 80125

City

Yaroslavl

ZIP/Postal Code

150010

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs

Dyslipidemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial