A clinical trial to study the effects of ZYH1 and Fenofibrate in patients with high lipid levels.(Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS I).
- Conditions
- Hyperlipidemia, unspecified,
- Registration Number
- CTRI/2010/091/000164
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
This was a Phase II, 12-Weeks, multicentre, double-blind, randomized, parallel group, prospective study with an open fenofibrate arm in male and female outpatients aged ≥ 18 years, comparing four doses (0.5 mg, 1 mg, 2 mg and 4 mg) of ZYH1 with the 160 mg dose of fenofibrate on lipid profile in subjects with dyslipidemia without type 2 diabetes. The Primary efficacy endpoints: 1.Triglyceride 2.Low density Lipoproteins ( LDL) cholesterol, 3.Very low density lipoprotein (VLDL) cholesterol, 4.HDL cholesterol and 5.Fasting Glucose. Secondary efficacy endpoints: 1.HbA1C, 2.Insulin and 3.C-Reactive protein(CRP) The efficacy variables were assessed as percent change at the end of treatment phase i.e., Week 12, as compared to start of treatment phase i.e., Week 0
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- Patients of either sex 18 years of age.
- Established diagnosis of dyslipidemia with BMI 23-42kg/m2 with fasting triglyceride level  150mg/dL.
- Normal routine hematological and biochemical test results.
1.Hypersensitivity to sulpha drugs or ZYH12.Pregnancy & Lactation.3.Patients with the active liver disease or hepatic dysfunction indicated by AST or ALT levels > or = 2.5 times the upper limit of normal.4.Patients with the history of myopathy or evidence of active muscle disease.5.Haemoglobin less than 11mg%6.Patients on concomitant medications known to affect the lipid levels and who does not want to enter in the wash out period.7.Patients with uncontrolled diabetes mellitus (fasting blood sugar > or =110 mg/dL).8.Patients with any other serious concurrent illness or malignancy.9.Presence or history of the gall stone.10.Patients with continuing history of alcohol and / or drug abuse.11.Participation in another clinical trial in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoints: 1.Triglyceride 2.Low density Lipoproteins ( LDL) cholesterol, 3.Very low density lipoprotein (VLDL) cholesterol, 4.HDL cholesterol and 5.Fasting Glucose. From baseline, visit 2(Week 0)to visit 8 (Week 12)
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints: 1.HbA1C,
Trial Locations
- Locations (4)
Grant Medical College & Sir J J Gr. of Govt. Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Le Bonheur Endocrine & Diabetes Clinic
🇮🇳Ahmadabad, GUJARAT, India
Pai Clinic & Diagnostic Centre
🇮🇳Pune, MAHARASHTRA, India
The Heart Care Clinic
🇮🇳Ahmadabad, GUJARAT, India
Grant Medical College & Sir J J Gr. of Govt. Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr. Alaka DeshpandePrincipal investigator09869168886alakadeshpande@rediffmail.com