A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Pravastatin
* Drug: Dalcetrapib
* Drug: Dalcetrapib
* Drug: Dalcetrapib


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalcetrapib 300mg<br> | Drug: Pravastatin<br>* 40mg po daily for 12 weeks<br>Drug: Dalcetrapib<br>* 300mg po daily for 12 weeks<br>|
| Experimental: Dalcetrapib 600mg<br> | Drug: Pravastatin<br>* 40mg po daily for 12 weeks<br>Drug: Dalcetrapib<br>* 600mg po daily for 12 weeks<br>|
| Experimental: Dalcetrapib 900mg<br> | Drug: Pravastatin<br>* 40mg po daily for 12 weeks<br>Drug: Dalcetrapib<br>* 900mg po daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* po daily for 12 weeks<br>Drug: Pravastatin<br>* 40mg po daily for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in HDL-C Level\n |  | Week 12 | 
| Percent Change From Baseline in HDL-C Level\n |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI |  | 12 weeks | 
| Percent Change of Fasting Glucose Level |  | 12 weeks | 
| AEs, Lab Parameters, Vital Signs, ECG |  | Through 9 Months | 
| Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB |  | Baseline and at 12 Weeks |