Evaluation of efficacy and safety of fixed dose combination of statin and cholecalciferol for the treatment of hyperlipidemia

Phase 3

Completed

• Conditions: Health Condition 1: null- patients with hyperlipidemia

• Registration Number: CTRI/2015/05/005778
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 335

Inclusion Criteria

1 Male or female patients aged between 18 to 70 years with hyperlipidemia.

2 Patients LDL level greater than or equal to 100 mg/dL with at least one risk factor OR LDL level greater than or equal to 130 mg/dL with no risk factor.

3 Treatment-Naïve Patients i.e., not currently on Statin or other Lipid lowering drugs or Vitamin D supplement.

4 Patients willing to give their informed consent.

Exclusion Criteria

1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.

2.Patient whose serum level of Vitamin D3 <10 nmol/L.

3.Patients with cardiovascular disease and/or type 1 diabetes mellitus.

4.Patients with significantly abnormal laboratory analysis of thyroid function.

5.Patients with severe renal impairment, including those receiving dialysis.

6.Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.

7.Patients with preexisting gallbladder disease.

8.Patients who is taking seizure drugs.

9.Patients who is taking steroids.

10.Patients with hypersensitivity to statin.

11.Patients taking oral coumarin anticoagulant.

12.Patients with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole).

13.Patient with history of alcohol abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
�Evaluation of Percent average change of LDL from baseline to end of treatment <br/ ><br>�Evaluation of Percent average change of TC from baseline to end of treatment <br/ ><br>Timepoint: Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), ), Visit 04 (Day 168 ± 2)