Combined Hyperlipidemia Clinical Trial
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.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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| Completed |
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