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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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia

Intervention: Fixed Combination of Fenofibrate/simvastatin 145/20 mg (Drug); Simvastatin 20 mg (Drug); Fenofibrate 145 mg (Drug); Fixed Combination of Fenofibrate/simvastatin 145/40 mg (Drug); Simvastatin 40 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Jean-Claude Ansquer, MD, Study Director, Affiliation: Abbott

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Percentage of Change of TG (Triglyceride)

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

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

Secondary outcome:

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

Percentage of TC (Triglyceride) From Baseline

Percentage of Apolipoprotein AI From Baseline

Percentage of Apolipoprotein B From Baseline

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

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

Adverse Events

Creatine Kinase (CK)

Alanine Aminotransferase (ALT)

Plasma Creatinine

Total Bilirubin

Cystatin C

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Site Reference ID/Investigator# 77956, Buenos Aires, Argentina

Site Reference ID/Investigator# 77957, Buenos Aires B1605DSX, Argentina

Site Reference ID/Investigator# 77958, Buenos Aires B1657BHD, Argentina

Site Reference ID/Investigator# 77959, Buenos Aires B1878GEG, Argentina

Site Reference ID/Investigator# 77960, Buenos Aires B1722COV, Argentina

Site Reference ID/Investigator# 77961, Buenos Aires 7600, Argentina

Site Reference ID/Investigator# 77965, Buenos Aires C1405BCH, Argentina

Site Reference ID/Investigator# 77967, Buenos Aires C1179AAB, Argentina

Site Reference ID/Investigator# 77968, Buenos Aires C1181ACK, Argentina

Site Reference ID/Investigator# 77969, Buenos Aires B2800DGH, Argentina

Site Reference ID/Investigator# 77966, Cipolletti - Rio Negro 8324, Argentina

Site Reference ID/Investigator# 77955, Santa Fe 3000, Argentina

Site Reference ID/Investigator# 77962, Santa Fe 3000, Argentina

Site Reference ID/Investigator# 77964, Santa Fe S2000DSV, Argentina

Site Reference ID/Investigator# 77963, Tucuman 4000JCU, Argentina

Site reference ID/Investigator # 99617, Benatky nad Jizerou 294 71, Czech Republic

Site reference ID/Investigator # 102335, Brno 65691, Czech Republic

Site Reference ID/Investigator# 80097, Brno 656 91, Czech Republic

Site Reference ID/Investigator# 80094, Prague 10 108 00, Czech Republic

Site Reference ID/Investigator# 80095, Prague 4 14059, Czech Republic

Site Reference ID/Investigator# 80093, Praha 8 18081, Czech Republic

Site Reference ID/Investigator# 80098, Teplice 415 01, Czech Republic

Site Reference ID/Investigator# 80096, Usti nad Labem 40113, Czech Republic

Site Reference ID/Investigator# 80099, Znojmo 669 02, Czech Republic

Site reference ID/Investigator # 97356, Berlin 10117, Germany

Site reference ID/Investigator # 97357, Berlin 13125, Germany

Site Reference ID/Investigator# 80100, Berlin 12351, Germany

Site Reference ID/Investigator# 90673, Berlin 10249, Germany

Site reference ID/Investigator # 102017, Dortmund 44137, Germany

Site reference ID/Investigator # 99876, Dresden 01069, Germany

Site Reference ID/Investigator# 80102, Dusseldorf 40597, Germany

Site Reference ID/Investigator# 80103, Essen 45359, Germany

Site Reference ID/Investigator# 80104, Essen 45355, Germany

Site Reference ID/Investigator# 80105, Frankfurt 60594, Germany

Site Reference ID/Investigator# 80101, Goch 47574, Germany

Site reference ID/Investigator # 99902, Hamburg 20253, Germany

Site reference ID/Investigator # 102015, Karlsruhe 76199, Germany

Site reference ID/Investigator # 102016, Koeln 51069, Germany

Site Reference ID/Investigator# 77970, Guadalajara, Jal. C.P. 44130, Mexico

Site Reference ID/Investigator# 77972, Mexico D.F. C.P. 11850, Mexico

Site Reference ID/Investigator# 77973, Mexico D.F. C.P. 06600, Mexico

Site Reference ID/Investigator# 77974, Zapopan 45200, Mexico

Site Reference ID/Investigator# 80111, Gdansk 80-952, Poland

Site Reference ID/Investigator# 80112, Gdansk 80-952, Poland

Site Reference ID/Investigator# 80110, Gdynia 81-423, Poland

Site Reference ID/Investigator# 80106, Katowice 40-954, Poland

Site Reference ID/Investigator# 80109, Plock 09-400, Poland

Site Reference ID/Investigator# 80108, Skierniewice 96-100, Poland

Site Reference ID/Investigator# 80107, Warsaw 01-868, Poland

Site reference ID/Investigator # 80115, Bucharest 10242, Romania

Site Reference ID/Investigator# 80113, Bucharest 42122, Romania

Site Reference ID/Investigator# 80114, Bucharest 11172, Romania

Site Reference ID/Investigator# 80116, Bucharest 20054, Romania

Site Reference ID/Investigator# 80117, Bucharest 11794, Romania

Site Reference ID/Investigator# 80119, Bucharest 22328, Romania

Site Reference ID/Investigator# 80118, Iasi 700547, Romania

Site Reference ID/Investigator# 80120, Kemerovo 650002, Russian Federation

Site Reference ID/Investigator# 80124, Moscow 119991, Russian Federation

Site Reference ID/Investigator# 80127, Moscow 125284, Russian Federation

Site Reference ID/Investigator# 80135, Moscow 119435, Russian Federation

Site Reference ID/Investigator# 80137, Moscow 119620, Russian Federation

Site Reference ID/Investigator# 80121, Novosibirsk 630047, Russian Federation

Site Reference ID/Investigator# 80122, Novosibirsk 630008, Russian Federation

Site Reference ID/Investigator# 80133, Novosibirsk 630068, Russian Federation

Site reference ID/Investigator # 80126, St. Petersburg 197022, Russian Federation

Site reference ID/Investigator # 80128, St. Petersburg 197022, Russian Federation

Site reference ID/Investigator # 80134, St. Petersburg 194156, Russian Federation

Site Reference ID/Investigator# 80136, St. Petersburg 199106, Russian Federation

Site Reference ID/Investigator# 80125, Yaroslavl 150010, Russian Federation

Additional Information

Starting date: June 2012
Last updated: November 24, 2014

Page last updated: August 23, 2015

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