A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia
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
2 other identifiers
interventional
109
1 country
18
Brief Summary
ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to decrease triglyceride level and also correct dyslipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedOctober 28, 2013
October 1, 2013
7 months
February 22, 2012
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Percentage change from baseline in lipid parameters
4 and 8 weeks
Study Arms (4)
ZYH7 4mg
EXPERIMENTALZYH7 4mg
ZYH7 8mg
EXPERIMENTALZYH7 8mg
ZYH7 16mg
EXPERIMENTALZYH7 16mg
Fenofibrate 160mg
ACTIVE COMPARATORFenofibrate 160mg
Interventions
Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.
Eligibility Criteria
You may qualify if:
- Age 18-65 years
- Subjects of either gender, males or females
- Triglycerides between 200 to 500 mg/dl on screening visit.
- Body mass index (BMI) \> 23 kg/m2
- If subject is diabetic, he should be controlled on a maximum of two oral anti diabetic agents except Thiazolidinedione.
- Subject has given informed consent for participation in this trial.
You may not qualify if:
- Pregnancy and lactation.
- History of 5% weight loss in past 6 months.
- Subjects on treatment with insulin and PPAR alpha or gamma agonist in the past 3 month.
- Subjects having unstable angina, acute myocardial infarction in past 3 months or heart failure of New York Heart Association (NYHA) class (III-IV).
- 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)
- History of clinically significant edema.
- History of pancreatitis or gall stone diseases.
- 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.
- Uncontrolled diabetes (HbA1c ≥ 9 gm %).
- 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.
- Renal dysfunction demonstrated by abnormal Glomerular Filtration Rate (GFR) (60 ml/min) or presence of ketonuria.
- History of myopathies or evidence of active muscle diseases demonstrated by Creatinine Phosphokinase(CPK) ≥ 10 times UNL.
- History of any other concurrent serious illness (e.g. tuberculosis, Human Immunodeficiency Virus(HIV) infection, malignancy, etc).
- History of alcohol and/or drug abuse.
- History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi
Ahmedabad, Gujarat, 380007, India
Devi Hospital,Ground floor, Naranpura
Ahmedabad, Gujarat, 380008, India
Private clinic, 4, Stadium House, Ground Floor, Navrangpura
Ahmedabad, Gujarat, 380009, India
Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi
Ahmedabad, Gujarat, 380015, 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
Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu
Chennai, Tamil Nadu, 600094, India
Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari
Vellore, Tamil Nadu, 632009, 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
Room no 3027,Research block B,Department of Endocrinology PGIMER
Chandigarh, 160012, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rajendra H Jani, Ph.D (Medical)
Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2012
First Posted
February 27, 2012
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
October 28, 2013
Record last verified: 2013-10