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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539616
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : October 28, 2013
Information provided by (Responsible Party):
Cadila Healthcare Limited

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Dyslipidemia Drug: ZYH7 Drug: Fenofibrate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Fenofibrate

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Percentage change in mean triglyceride level from baseline [ Time Frame: 4 and 8 weeks ]
    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 :
  1. Percentage change from baseline in lipid parameters [ Time Frame: 4 and 8 weeks ]

    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01539616

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Sponsors and Collaborators
Cadila Healthcare Limited
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Study Director: Rajendra H Jani, Ph.D (Medical) Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited
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Responsible Party: Cadila Healthcare Limited Identifier: NCT01539616    
Other Study ID Numbers: ZYH7.10.001.01
CTRI/2011/11/002147 ( Registry Identifier: Clinical Trials Registry - India )
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013
Keywords provided by Cadila Healthcare Limited:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents