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A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia

NCT01539616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2013-10-28

No results posted yet for this study

Summary

ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to decrease triglyceride level and also correct dyslipidemia.

Conditions

Interventions

DRUG

ZYH7

ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.

DRUG

ZYH7

ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.

DRUG

ZYH7

ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.

DRUG

Fenofibrate

Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Rajendra H Jani, Ph.D (Medical) · Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01539616 on ClinicalTrials.gov