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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited
ClinicalTrials.gov Identifier:
NCT01539616
First received: February 22, 2012
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Hypertriglyceridemia
Dyslipidemia
Drug: ZYH7
Drug: Fenofibrate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Cadila Healthcare Limited:

Primary Outcome Measures:
  • Percentage change in mean triglyceride level from baseline [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
    Percentage change in mean triglyceride levels from baseline within and across each treatment of ZYH7 The changes will be compared with fenofibrate 160mg.


Secondary Outcome Measures:
  • Percentage change from baseline in lipid parameters [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

    Percentage change from baseline in the following lipid parameters:

    1. Low Density Lipoprotein Cholesterol(LDL)
    2. Very Low Density Lipoprotein Cholesterol (VLDL)
    3. High Density Lipoprotein (HDL)
    4. Total cholesterol
    5. Non HDL Cholesterol (Measured value)
    6. Apo A
    7. Apo B
    8. High sensitive C-Reactive Protein (hs-CRP)


Enrollment: 109
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZYH7 4mg
ZYH7 4mg
Drug: ZYH7
ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
Experimental: ZYH7 8mg
ZYH7 8mg
Drug: ZYH7
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
Experimental: ZYH7 16mg
ZYH7 16mg
Drug: ZYH7
ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
Active Comparator: Fenofibrate 160mg
Fenofibrate 160mg
Drug: Fenofibrate
Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539616

Locations
India
Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi
Ahmedabad, Gujarat, India, 380007
Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi
Ahmedabad, Gujarat, India, 380015
Private clinic, 4, Stadium House, Ground Floor, Navrangpura
Ahmedabad, Gujarat, India, 380009
Devi Hospital,Ground floor, Naranpura
Ahmedabad, Gujarat, India, 380008
Govt. Medical College, Bhavnagar
Bhavnagar, Gujarat, India, 364001
Gastrocare Clinic,Ground floor, Karansinhji Main Road,
Rajkot, Gujarat, India, 360001
Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura,
Vadodara, Gujarat, India, 390 023
Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi
Bangalore, Karnataka, India, 560 043
Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage
Bangalore, Karnataka, India, 560085
Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,
Davangere, Karnataka, India, 577002
Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station
Aurangabad, Maharashtra, India, 431001
Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,
Mumbai, Maharashtra, India, 400007
Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House
Pune, Maharashtra, India, 411005
Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road
Jaipur, Rajasthan, India, 302024
Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari
Vellore, Tamil Nadu, India, 632009
Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu
Chennai, Tamilnadu, India, 600094
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, 700020
Room no 3027,Research block B,Department of Endocrinology PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Cadila Healthcare Limited
Investigators
Study Director: Rajendra H Jani, Ph.D (Medical) Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited
  More Information

No publications provided

Responsible Party: Cadila Healthcare Limited
ClinicalTrials.gov Identifier: NCT01539616     History of Changes
Other Study ID Numbers: ZYH7.10.001.01, CTRI/2011/11/002147
Study First Received: February 22, 2012
Last Updated: October 25, 2013
Health Authority: India: Central Drugs Standard Control Organization
United States: Food and Drug Administration

Keywords provided by Cadila Healthcare Limited:
Hypertriglyceridemia
Dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Hypertriglyceridemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014