A clinical trial to evaluate the safety and efficacy of ZYH7 compared to Fenofibrate in patients with dyslipidemia

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Inclusion criteria :

1.Age 18-65 years

2.Subjects of either gender, males or females

3.Triglycerides more than or equal to 200 to 500 mg/dl on screening visit.

4.Body mass index (BMI) more than 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

Exclusion criteria :

1.Pregnancy and lactation.

2.History of more than 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 NYHA class (III-IV).

5.Uncontrolled hypertension ( more than 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 more than or equal to 9 gm %).

10.History of active liver disease or hepatic dysfunction demonstrated by AST and ALT more than or equal to 2.5 times of upper normal limit (UNL) or bilirubin more than or equal to 2 times UNL in the past 3 months.

11.Renal dysfunction demonstrated by abnormal GFR (more than 60 ml per min) or presence of ketonuria.

12.History of myopathies or evidence of active muscle diseases demonstrated by CPK more than or equal to 10 times UNL.

13.History of any other concurrent serious illness (e.g. tuberculosis, HIV, 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.

17.If on contraceptive or hormone replacement therapy (HRT), therapy started or changed in last 3 months.

18.Prolonged use of steroids (more than 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. (more than 1month)

20.Participation in any other clinical trial in the past 3 months

21.Unable to give informed consent and follow protocol requirements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean triglyceride level from baseline across various treatment groups.Timepoint: Visit2,Visit3,Visit4,Visit5

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy endpoints are change in mean from baseline across various treatment groups on following parameters: <br/ ><br>1.LDL <br/ ><br>2.VLDL <br/ ><br>3.HDL <br/ ><br>4.Total cholesterol <br/ ><br>5.Non HDL Cholesterol (Measured value) <br/ ><br>6.Apo A <br/ ><br>7.Apo B <br/ ><br>8.hs-CRP <br/ ><br>Timepoint: Visit2,Visit3,Visit4,Visit5