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Sponsors and Collaborators: |
Sciele Pharma Integrium |
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Information provided by: | Sciele Pharma |
ClinicalTrials.gov Identifier: | NCT00459745 |
This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study with a 52-week open-label follow-up to evaluate the safety and efficacy of daily administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia. There will be an open-label, 8-week, Selection Phase prior to randomization in which all patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm, double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg). The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which all patients will receive Pravafen.
After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the completion of the 12-week double-blind phase of the study, all patients that haven't had changes in their well being, will be allowed to roll-over into the 52-week, open-label, follow-up portion of the study. During the 52 week, open label, Safety Phase of the study, all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg).
Patients will be evaluated at baseline and every three weeks thereafter throughout the initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week, open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks.
Participation in the study can be up to 72 weeks.
Condition | Intervention | Phase |
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Combined Hyperlipidemia |
Drug: Pravastatin Drug: Fenofibrate Drug: Pravafen (Combination of Pravastatin and Fenofibrate) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the Combination of Pravastatin and Fenofibrate 40/160 mg) for 12 Weeks Followed by a 52-Week Open-Label Safety Phase of the Pravafen Alone in the Treatment of Combined Hyperlipidemia. |
Estimated Enrollment: | 500 |
Study Start Date: | April 2007 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients meeting all the criteria listed below may be selected to enroll into the Selection Phase of the study:
High LDL cholesterol and TG levels as per the table hereunder:
Prior treatment LDL Cholesterol TG Naïve to treatment* > 130 mg/dL and ≥ 150 mg/dL and ≤ 400 mg/dL Lipid Lowering Monotherapy > 130 mg/dL and ≥ 150 mg/dL and ≤ 400 mg/dL Lipid Lowering Combination Therapy > 110 mg/dL and ≥ 150 mg/dL and ≤ 400 mg/dL
At the end of the Selection Phase, patients meeting all of the criteria listed below may be selected and randomized into the Efficacy Phase of the study:
Exclusion Criteria:
Patients will be excluded from the study if any one or more of the following apply:
History of allergy or contraindications to:
History of uncontrolled or unstable;
Positive personal history of abuse of any of the following:
Usage of any of the following medications (patients must have discontinued these medications for 5 or more half-lives or for 30 days, whichever is greater prior to study drug administration on Visit 3 / Day 0) :
Presence of any other condition or illness, which, in the opinion of the Principal Investigator, would interfere with the patient's participation in the study
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Responsible Party: | Sciele Pharma, Inc. |
Study ID Numbers: | Sc-PRAVA-06-02 |
Study First Received: | April 9, 2007 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00459745 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cardiovascular Disease Fenofibrate LDL cholesterol HDL cholesterol |
Hyperlipidemia Pravastatin Triglycerides |
Antimetabolites Pravastatin Metabolic Diseases Hyperlipidemias Antilipemic Agents Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Procetofen Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Procetofen Pharmacologic Actions Pravastatin Therapeutic Uses Dyslipidemias Lipid Metabolism Disorders |