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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Pravastatin
Dalcetrapib
Dalcetrapib
Dalcetrapib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dalcetrapib 300mg

Dalcetrapib 600mg

Dalcetrapib 900mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in HDL-C Level\n
Percent Change From Baseline in HDL-C Level\n

Secondary Outcome Measures

Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
Percent Change of Fasting Glucose Level
AEs, Lab Parameters, Vital Signs, ECG
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB

Full Information

First Posted
June 11, 2008
Last Updated
December 13, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00697203
Brief Title
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dalcetrapib 300mg
Arm Type
Experimental
Arm Title
Dalcetrapib 600mg
Arm Type
Experimental
Arm Title
Dalcetrapib 900mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Intervention Description
40mg po daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Dalcetrapib
Intervention Description
300mg po daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Dalcetrapib
Intervention Description
600mg po daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Dalcetrapib
Intervention Description
900mg po daily for 12 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in HDL-C Level\n
Time Frame
Week 12
Title
Percent Change From Baseline in HDL-C Level\n
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
Time Frame
12 weeks
Title
Percent Change of Fasting Glucose Level
Time Frame
12 weeks
Title
AEs, Lab Parameters, Vital Signs, ECG
Time Frame
Through 9 Months
Title
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB
Time Frame
Baseline and at 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610-4319
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
City
Chalmette
State/Province
Louisiana
ZIP/Postal Code
70043
Country
United States
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Springdale
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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