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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539616
• Other study ID #: ZYH7.10.001.01
• Secondary ID: CTRI/2011/11/002
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2012
• Last updated: October 25, 2013
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: Cadila Healthcare Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Central Drugs Standard Control OrganizationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertriglyceridemia

Intervention

Drug:
• ZYH7
ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
• ZYH7
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
• ZYH7
ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
• Fenofibrate
Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.

Locations

Country	Name	City	State
India	Devi Hospital,Ground floor, Naranpura	Ahmedabad	Gujarat
India	Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi	Ahmedabad	Gujarat
India	Private clinic, 4, Stadium House, Ground Floor, Navrangpura	Ahmedabad	Gujarat
India	Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi	Ahmedabad	Gujarat
India	Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station	Aurangabad	Maharashtra
India	Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi	Bangalore	Karnataka
India	Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage	Bangalore	Karnataka
India	Govt. Medical College, Bhavnagar	Bhavnagar	Gujarat
India	Room no 3027,Research block B,Department of Endocrinology PGIMER	Chandigarh
India	Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu	Chennai	Tamilnadu
India	Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,	Davangere	Karnataka
India	Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road	Jaipur	Rajasthan
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
India	Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,	Mumbai	Maharashtra
India	Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House	Pune	Maharashtra
India	Gastrocare Clinic,Ground floor, Karansinhji Main Road,	Rajkot	Gujarat
India	Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura,	Vadodara	Gujarat
India	Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari	Vellore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Healthcare Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage change from baseline in lipid parameters	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)	4 and 8 weeks	No