DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Cadila Healthcare Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertriglyceridemia; Dyslipidemia

Intervention: ZYH7 (Drug); ZYH7 (Drug); ZYH7 (Drug); Fenofibrate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Cadila Healthcare Limited

Official(s) and/or principal investigator(s):
Rajendra H Jani, Ph.D (Medical), Study Director, Affiliation: Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage change in mean triglyceride level from baseline

Secondary outcome: Percentage change from baseline in lipid parameters

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age 18-65 years 2. Subjects of either gender, males or females 3. Triglycerides between 200 to 500 mg/dl on screening visit. 4. Body mass index (BMI) > 23 kg/m2 5. If subject is diabetic, he should be controlled on a maximum of two oral anti diabetic agents except Thiazolidinedione. 6. Subject has given informed consent for participation in this trial. Exclusion Criteria: 1. Pregnancy and lactation. 2. History of 5% weight loss in past 6 months. 3. Subjects on treatment with insulin and PPAR alpha or gamma agonist in the past 3 month. 4. Subjects having unstable angina, acute myocardial infarction in past 3 months or heart failure of New York Heart Association (NYHA) class (III-IV). 5. Uncontrolled hypertension (150/100 mm of Hg).(If Subject using Thiazides, ACE inhibitors, beta blockers they should be on minimum 3 month stable therapy and treatment not expected to change during trial participation) 6. History of clinically significant edema. 7. History of pancreatitis or gall stone diseases. 8. Subject having thyroid-stimulating hormone (TSH) levels outside normal reference range, Subjects who are clinically euthyroid and on stable thyroid replacement therapy for 2 months prior to screening and who are anticipated to remain on this dose throughout the trial period will be allowed. 9. Uncontrolled diabetes (HbA1c ≥ 9 gm %). 10. History of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and Alanine Aminotransferase(ALT) ≥ 2. 5 times of upper normal limit (UNL) or bilirubin ≥ 2 times UNL in the past 3 months. 11. Renal dysfunction demonstrated by abnormal Glomerular Filtration Rate (GFR) (60 ml/min) or presence of ketonuria. 12. History of myopathies or evidence of active muscle diseases demonstrated by Creatinine Phosphokinase(CPK) ≥ 10 times UNL. 13. History of any other concurrent serious illness (e. g. tuberculosis, Human Immunodeficiency Virus(HIV) infection, malignancy, etc). 14. History of alcohol and/or drug abuse. 15. History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients. 16. Subjects on any other lipid lowering medications. (Appendix I). 17. If on contraceptive or hormone replacement therapy (HRT), therapy started or changed in last 3 months. 18. Prolonged use of steroids (15 days) in last 3 months (topical preparations, nasal and intra-articular administration are permitted). 19. History of long term use of non-steroidal anti-inflammatory drugs. (1 month) 20. Participation in any other clinical trial in the past 3 months 21. Unable to give informed consent and follow protocol requirements.

Locations and Contacts

Room no 3027,Research block B,Department of Endocrinology PGIMER, Chandigarh 160012, India

Devi Hospital,Ground floor, Naranpura, Ahmedabad, Gujarat 380008, India

Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi, Ahmedabad, Gujarat 380015, India

Private clinic, 4, Stadium House, Ground Floor, Navrangpura, Ahmedabad, Gujarat 380009, India

Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi, Ahmedabad, Gujarat 380007, 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

Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari, Vellore, Tamil Nadu 632009, India

Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu, Chennai, Tamilnadu 600094, 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

Additional Information

Starting date: November 2011
Last updated: October 25, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017