A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia
NCT ID: NCT01539616
Last Updated: 2013-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2011-11-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ZYH7 4mg
ZYH7 4mg
ZYH7
ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
ZYH7 8mg
ZYH7 8mg
ZYH7
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
ZYH7 16mg
ZYH7 16mg
ZYH7
ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
Fenofibrate 160mg
Fenofibrate 160mg
Fenofibrate
Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Zydus Lifesciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Rajendra H Jani, Ph.D (Medical)
Role: STUDY_DIRECTOR
Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited
Locations
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Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi
Ahmedabad, Gujarat, India
Devi Hospital,Ground floor, Naranpura
Ahmedabad, Gujarat, India
Private clinic, 4, Stadium House, Ground Floor, Navrangpura
Ahmedabad, Gujarat, India
Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi
Ahmedabad, Gujarat, India
Govt. Medical College, Bhavnagar
Bhavnagar, Gujarat, 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
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
Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,
Davangere, Karnataka, India
Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station
Aurangabad, Maharashtra, 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
Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road
Jaipur, Rajasthan, India
Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu
Chennai, Tamil Nadu, India
Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari
Vellore, Tamil Nadu, 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
Room no 3027,Research block B,Department of Endocrinology PGIMER
Chandigarh, , India
Countries
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Other Identifiers
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CTRI/2011/11/002147
Identifier Type: REGISTRY
Identifier Source: secondary_id
ZYH7.10.001.01
Identifier Type: -
Identifier Source: org_study_id