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Trial information
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
Status: Completed
Protocol number: NC18589
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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.
Target sample size is 240.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Dyslipidemia
Intervention type: Drug
Intervention name: RO4607381
Primary outcome: 1. Percentage and absolute change from baseline in HDL-C level
Time frame: Week 12
Key secondary outcomes: 1. Change from baseline in: TC, TG, HDL-C, LDL-C, HDL-2, HDL-3, ApoAI, ApoAII, ApoB, ApoE, LpAI, oxidized LDL, and ratios of these lipid parameters
Time frame: 12 week period of double-blind treatment
2. Fasting glucose and insulin levels Time frame: 12 week period of double-blind treatment
3. AEs, lab parameters, vital signs, ECG Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:United States - Mobile, AL
- Scottsdale, AZ
- Newark, DE
- Miami, FL
- Chicago, IL
- Evansville, IN
- Indianapolis , IN
- Iowa City, IA
- Overland Park, KS
- Wichita, KS
- Louisville, KY
- Slidell, LA
- Auburn, ME
- Scarborough, ME
- Baltimore, MD
- Bethesda, MD
- Towson, MD
- St Louis, MO
- Concord, NH
- Charlotte, NC
- Statesville, NC
- Winston-Salem, NC
- Cincinnati, OH
- Springdale, OH
- Oklahoma City, OK
- Philadelphia, PA
- Warminster, PA
- Houston, TX
- Richmond, VA
- Seattle, WA
- Madison, WI
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