A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | July 2005 |
| End Date: | May 2006 |
A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels
This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered
with pravastatin in patients with low or relatively low HDL-C levels. Patients will be
randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or
placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for
12 weeks.The anticipated time on study treatment is 3 months and the target sample size is
100-500 individuals.
with pravastatin in patients with low or relatively low HDL-C levels. Patients will be
randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or
placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for
12 weeks.The anticipated time on study treatment is 3 months and the target sample size is
100-500 individuals.
Inclusion Criteria:
- adult patients 18-75 years of age;
- dyslipidemic patients with low or relatively low HDL-C levels during treatment with
pravastatin.
Exclusion Criteria:
- women who are pregnant, breastfeeding, or of child-bearing potential;
- morbid obesity;
- uncontrolled hypertension;
- poorly controlled or insulin-treated diabetes;
- high creatinine levels or history of statin-associated myopathy.
We found this trial at
33
sites
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415 Curie Boulevard
Philidelphia, Pennsylvania 19104
Philidelphia, Pennsylvania 19104
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