AN OPEN-LABEL PHASE III, STUDY TO EVALUATE THE SAFETY OF THE COMBINATION (FENOFIBRATE / PRAVASTATIN 160-40 MG) DURING 24 WEEKS, IN HIGH VASCULAR RISK PATIENTS WITH COMBINED HYPERLIPIDEMIA - PRAVAFEN SAFETY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

Male or female, 18 years and older
High vascular risk patients according to the NCEP ATP III definitions with combined hyperlipidemia
Patients following a standardized diet for at least three months before the screening visit to be maintained stable throughout the study.
Patients taking a statin therapy for at least 8 weeks (stable dose) at the selection visit
Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form
If the patient is female and of childbearing potential, she must be using an efficient mean of birth control, as determined by the investigator and provide a negative serum pregnancy test at the selection visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Secondary or iatrogenic dyslipidemia
Hyperlipidemia type I-IIa-IV-V
Abnormal liver function
CPK > 3x ULN
Abnormal renal function
Uncontrolled hypertension, as defined by SBP > 160 mm Hg or DBP > 95 mmHg under blood pressure treatment
Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease
Uncontrolled primary hypothyroidism
Uncontrolled diabetes with Hb1Ac > 8.5%
Use of any of the prohibited medication as detailed in the concomitant medication section
Patients with poor cognitive function
Participation in any other clinical trial within 3 months of the selection visit
Childbearing potential woman not using an appropriate contraceptive method, pregnant or breastfeeding woman
Patients with a biliary tract disease
Patients with high alcohol consumption or with a recent history of alcoholism
Patients with a personal or family history of hereditary muscle disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

An Open Label, Phase-III Study to Evaluate the Safety and Immunogenicity of Influenza Vaccine

CompletedPhase 3

G C CHEMIE PHARMIE LTD

Updated 11/24/2021

A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

Phase 1

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Updated 1/9/2023

A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

Phase 1

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Updated 3/2/2022

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

Phase 1

IB Therapeutics, LLC

Updated 4/4/2022

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

RecruitingPhase 1

ib Therapeutics LLC

Updated 7/22/2024

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

Phase 1

IB Therapeutics, LLC

Updated 4/22/2024

An open label extension study to evaluate the long term efficacy and safety of LIB-003 in patients with familial hypercholesterolemia, very high or high risk for cardiovascular disease who are on stable lipid-lowering therapy requiring additional LDL-C reduction (LIBerate-OLE).

Phase 3

IB Therapeutics LLC

Updated 4/3/2023

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

Phase 1

IB Therapeutics, LLC

Updated 4/22/2024

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

Phase 1

IB Therapeutics, LLC

Updated 4/29/2024

A Phase III, Open-Label Extension Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia, evaluating the Safety and Efficacy of Ferumoxytol

Phase 1

AMAG Pharmaceuticals, Inc.

Updated 4/19/2022

AN OPEN-LABEL PHASE III, STUDY TO EVALUATE THE SAFETY OF THE COMBINATION (FENOFIBRATE / PRAVASTATIN 160-40 MG) DURING 24 WEEKS, IN HIGH VASCULAR RISK PATIENTS WITH COMBINED HYPERLIPIDEMIA - PRAVAFEN SAFETY

Recruitment & Eligibility

Study & Design

Related Trials

An Open Label, Phase-III Study to Evaluate the Safety and Immunogenicity of Influenza Vaccine

A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

An open label extension study to evaluate the long term efficacy and safety of LIB-003 in patients with familial hypercholesterolemia, very high or high risk for cardiovascular disease who are on stable lipid-lowering therapy requiring additional LDL-C reduction (LIBerate-OLE).

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

A Phase III, Open-Label Extension Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia, evaluating the Safety and Efficacy of Ferumoxytol

Clinical Trial Alerts

Clinical Trial Alerts