Clinical trial NCT01539616: A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Dyslipidemia
Keywords: Hypertriglyceridemia
Dyslipidemia
Lead sponsor: Zydus Lifesciences Limited
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage change in mean triglyceride level from baseline
timeFrame: 4 and 8 weeks
Secondary outcomes:
measure: Percentage change from baseline in lipid parameters
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi
state: Gujarat
city: Ahmedabad
country: India
facility: Devi Hospital,Ground floor, Naranpura
state: Gujarat
city: Ahmedabad
country: India
facility: Private clinic, 4, Stadium House, Ground Floor, Navrangpura
state: Gujarat
city: Ahmedabad
country: India
facility: Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi
state: Gujarat
city: Bhavnagar
country: India
facility: Govt. Medical College, Bhavnagar
state: Gujarat
city: Rajkot
country: India
facility: Gastrocare Clinic,Ground floor, Karansinhji Main Road,
state: Gujarat
city: Vadodara
country: India
facility: Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura,
state: Gujarat
city: Bangalore
country: India
facility: Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi
state: Karnataka
city: Bangalore
country: India
facility: Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage
state: Karnataka
city: Davangere
country: India
facility: Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,
state: Karnataka
city: Aurangabad
country: India
facility: Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station
state: Maharashtra
city: Mumbai
country: India
facility: Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,
state: Maharashtra
city: Pune
country: India
facility: Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House
state: Maharashtra
city: Jaipur
country: India
facility: Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road
state: Rajasthan
city: Vellore
country: India
facility: Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari
state: Tamil Nadu
city: Chennai
country: India
facility: Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu
state: Tamilnadu
city: Kolkata
country: India
facility: Department of Endocrinology, Room No.9, 4 th Floor, Ronald Ross Building, Institute of Post Graduate Medical Education & Research, 244 AJC Bose Road.
state: West Bengal
city: Chandigarh
country: India
facility: Room no 3027,Research block B,Department of Endocrinology PGIMER
Study officials:
affiliation: Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited
name: Rajendra H Jani, Ph.D (Medical)
role: STUDY_DIRECTOR
References: