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
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