NCT01539616

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

A Multicentric Prospective Randomized Double Blind Parallel Group Active Controlled Study to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypertriglyceridemia
• Dyslipidemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2012-02-27
• Last updated: 2013-10-28

Locations

18 sites across 1 country: India