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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2011/11/002147 | Registry Identifier | Clinical Trials Registry - India |
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ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to decrease triglyceride level and also correct dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZYH7 4mg | Experimental | ZYH7 4mg |
|
| ZYH7 8mg | Experimental | ZYH7 8mg |
|
| ZYH7 16mg | Experimental | ZYH7 16mg |
|
| Fenofibrate 160mg | Active Comparator | Fenofibrate 160mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZYH7 | Drug | ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in mean triglyceride level from baseline | Percentage change in mean triglyceride levels from baseline within and across each treatment of ZYH7 The changes will be compared with fenofibrate 160mg. | 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in lipid parameters | Percentage change from baseline in the following lipid parameters:
| 4 and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajendra H Jani, Ph.D (Medical) | Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi | Ahmedabad | Gujarat | 380007 | India |
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| ZYH7 |
| Drug |
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks. |
|
| ZYH7 | Drug | ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks. |
|
| Fenofibrate | Drug | Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks. |
|
| Devi Hospital,Ground floor, Naranpura | Ahmedabad | Gujarat | 380008 | India |
| Private clinic, 4, Stadium House, Ground Floor, Navrangpura | Ahmedabad | Gujarat | 380009 | India |
| Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi | Ahmedabad | Gujarat | 380015 | India |
| Govt. Medical College, Bhavnagar | Bhavnagar | Gujarat | 364001 | India |
| Gastrocare Clinic,Ground floor, Karansinhji Main Road, | Rajkot | Gujarat | 360001 | India |
| Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura, | Vadodara | Gujarat | 390 023 | India |
| Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi | Bangalore | Karnataka | 560 043 | India |
| Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage | Bangalore | Karnataka | 560085 | India |
| Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN, | Davangere | Karnataka | 577002 | India |
| Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station | Aurangabad | Maharashtra | 431001 | India |
| Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room, | Mumbai | Maharashtra | 400007 | India |
| Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House | Pune | Maharashtra | 411005 | India |
| Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road | Jaipur | Rajasthan | 302024 | India |
| Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu | Chennai | Tamil Nadu | 600094 | India |
| Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari | Vellore | Tamil Nadu | 632009 | India |
| Department of Endocrinology, Room No.9, 4 th Floor, Ronald Ross Building, Institute of Post Graduate Medical Education & Research, 244 AJC Bose Road. | Kolkata | West Bengal | 700020 | India |
| Room no 3027,Research block B,Department of Endocrinology PGIMER | Chandigarh | 160012 | India |
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
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