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A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels

NCT01388816 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2014-04-22

Study results available
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Summary

The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.

Conditions

  • Type II Hyperlipidemia

Interventions

DRUG

DRL-17822 or placebo

DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast

Sponsors & Collaborators

  • PharmaNet

    collaborator INDUSTRY

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Kent Allenby, MD · Dr. Reddy's Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Italy
  • Poland
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388816 on ClinicalTrials.gov