Phase 2 Completed N=292 Randomized Double-blind Treatment

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

Dyslipidemia

Source: ClinicalTrials.gov NCT00697203 ↗

Enrolled (actual)

292

Serious AEs

3.1%

Results posted

Jan 2020

Primary outcomePrimary: Absolute Change From Baseline in HDL-C Level\n — 17.18; 31.42; 36.45; 2.31 mg/dL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Absolute Change From Baseline in HDL-C Level\n	17.18; 31.42; 36.45; 2.31	—
PRIMARY Percent Change From Baseline in HDL-C Level\n	6.58; 11.90; 13.92; 0.73	—
SECONDARY Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI	7.08; 12.58; 9.36; 1.35; -5.95; 4.45	—
SECONDARY Percent Change of Fasting Glucose Level	3.61; 6.03; 5.42; 3.00	—
SECONDARY AEs, Lab Parameters, Vital Signs, ECG	—	—
SECONDARY Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB	-3.76; -16.0; -19.4; 3.09; -4.97; -5.79	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00697203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.