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

Phase 3

Completed

• Conditions: patients with hyperlipidemia

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

Brief Summary

This was a Phase III, an open-label, randomized, comparative, multicentric study in which efficacy and safety of the FDC of Atorvastatin + Vitamin D3 was determined in 335 patients at 11 different centers across different geographies in India. Patients were randomized to receive either FDC of Atorvastatin (10mg/20mg) + Vitamin D3 / OD or Atorvastatin/(10mg/20mg) / OD alone. Vitamin D3 (60,000 IU) sachet was given to patients who were on fixed dose combination of Atorvastatin + Vitamin D3 group once in a week for 8 weeks. Male or female subjects aged between 18-70 years with hyperlipidemia, fulfilling all the inclusion criteria and none of the exclusion criteria were enrolled in the study. Patients were evaluated for percent average change in serum LDL and total cholesterol level from baseline to end of the treatment as primary efficacy variables. Percent average change in serum HDL, TG and Vitamin D3 level were measured as secondary efficacy variables. Blood samples were collected for laboratory testing of hemoglobin, total and differential WBC count, total bilirubin, SGOT and SGPT, serum creatinine, urine analysis at screening visit and at end of the study. ECG was performed at screening visit and at end of study.

The duration of study participation of each patient was up to 25 weeks (i.e., 01 week of screening period and 24 weeks of treatment period).

Based on the study results it is concluded that FDC [Atorvastatin 10/20 mg and Vitamin D3 (1000 IU)] is safe and effective in patients with hyperlipidemia. It is especially useful in patients with baseline Vitamin D3 level < 30 nmol/L. In this population supplementation of Vitamin D3 with Atorvastatin has been shown to cause (1) clinically relevant faster reduction in LDL and total cholesterol in comparison to Atorvastatin alone and (2) exert similar action to the one observed with double dose of Atorvastatin. This effect is relevant in Indian population wherein a larger population is deficient in Vitamin D3.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-07
• Study Completion: 2016-12-31
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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	Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), ), Visit 04 (Day 168 ± 2)
•Evaluation of Percent average change of TC from baseline to end of treatment	Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), ), Visit 04 (Day 168 ± 2)

Secondary Outcome Measures

Name	Time	Method
Treatment Emergent AEs (Adverse Events) / monitoring of AEs and SAEs (Serious Adverse Events) throughout the study period	Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), Visit 04 (Day 168 ± 2)
Evaluation of Percent average change of HDL from baseline to end of treatment	Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), Visit 04 (Day 168 ± 2)
Evaluation of Percent average change of Vitamin D3 level from baseline to end of treatment	Visit 01 (Day 0) and Visit 04 (Day 168 ± 2)
Evaluation of Percent average change of TG from baseline to end of treatment	Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), Visit 04 (Day 168 ± 2)
Assessment of laboratory parameters from baseline to end of treatment (Hemoglobin, Total and differential WBC count, SGOT, SGPT, Total bilirubin, Serum Creatinine and urine analysis	Visit 01 (Day 0) and Visit 04 (Day 168 ± 2)
ECG assessment at baseline and end of the treatment	Visit 01 (Day 0) and Visit 04 (Day 168 ± 2)

Trial Locations

Locations (11)

Ashirwad Hospital & Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Aster Aadhar Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Calcutta Medical College; 🇮🇳 Kolkata, WEST BENGAL, India

GMERS Medical College & Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

IPGME & R/SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Kanoria Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

Medilink Hospital and Research Center; 🇮🇳 Ahmadabad, GUJARAT, India

Osmania General Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Shat Aayu Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Shatabdi Super Speciality Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Scroll for more (1 remaining)

Ashirwad Hospital & Research Centre

🇮🇳Thane, MAHARASHTRA, India

Dr Shrikant Deshpande

Principal investigator

9822017445

svshrikant@gmail.com