A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia
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|ClinicalTrials.gov Identifier: NCT01539616|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : October 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertriglyceridemia Dyslipidemia||Drug: ZYH7 Drug: Fenofibrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||August 2012|
Experimental: ZYH7 4mg
ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
Experimental: ZYH7 8mg
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
Experimental: ZYH7 16mg
ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
Active Comparator: Fenofibrate 160mg
Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.
- Percentage change in mean triglyceride level from baseline [ Time Frame: 4 and 8 weeks ]Percentage change in mean triglyceride levels from baseline within and across each treatment of ZYH7 The changes will be compared with fenofibrate 160mg.
- Percentage change from baseline in lipid parameters [ Time Frame: 4 and 8 weeks ]
Percentage change from baseline in the following lipid parameters:
- Low Density Lipoprotein Cholesterol(LDL)
- Very Low Density Lipoprotein Cholesterol (VLDL)
- High Density Lipoprotein (HDL)
- Total cholesterol
- Non HDL Cholesterol (Measured value)
- Apo A
- Apo B
- High sensitive C-Reactive Protein (hs-CRP)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539616
|Study Director:||Rajendra H Jani, Ph.D (Medical)||Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited|