An Observational Post Marketing study to check the safety and tolerance of Atorsave D on patients with hyperlipidemia or statin related myalgia.

Not Applicable

Completed

• Conditions: Other disorder of circulatory system, Patients with hyperlipidemia or statin related myalgia,

• Registration Number: CTRI/2017/09/009644
• Lead Sponsor: Eris Life sciences Pvt Ltd

Brief Summary

·         This is a phase IV, randomized, open label and multicentre study, designed to evaluate the safety and tolerability of study drug Atorsave D.

·       Approximately 144 patients will be enrolled to get complete data of 120 patients from multiple sites in India. This will be a prescription-based study.

·       This study will include patients with hyperlipidemia or statin induced myalgia in accordance with the respective local prescribing information and routine clinical practice.

·       Patients eligible for participation in this study will, as part of their routine medical care, receive Atorsave D tablets.

·       Recommended data collection time points are intended to be aligned with most local labels and patterns of care that most patients will receive in routine clinical practice. Since this is a post marketing study, there are no special protocol–mandated procedures associated with the study. However whenever applicable, evaluations documented in the eCRF are expected to be aligned with the local prescribing information recommendations and individual clinician practice. Information on safety areas of specific interest will be specifically collected. The potential patients will be enrolled as per the inclusion and exclusion criteria only after obtaining written informed consent from each patient.

·         Patients will be dosed with Atorsave D for 8 weeks.

·         Patients will be instructed not to take supplemental vitamins. The patients treated with Atorsave D will be followed for assessment of safety parameters throughout the study.

·         Overall assessment for safety & tolerability in the patients will be assessed by investigator during the 8 week study.

·         Safety assessment will include monitoring of AEs, SAEs, physical examination results, vital signs and clinical laboratory results

·         Physical examination including vital signs will be done at baseline as well as at every follow-up visit (4 weeks & 8 weeks)or before discontinuation from the study..

·         Standard 12 lead ECG will be done at baseline as well as at end of treatment (8 weeks) or before patient’s discontinuation from the study.

·         Blood & urine samples will be collected for laboratory investigations at baseline as well as at the end of treatment (8 weeks) or before patient’s discontinuation from the study.

·         Visual analogue scale (VAS) scores for myalgia will be recorded [(myalgia score (range, 0 to 100 mm)] before the administration of first dose of Atorsave D, after 4 weeks and at the end of the treatment ( 8 weeks).

·         For QoL assessment, SF-12 questionnaire will be administered before the administration of first dose of Atorsave D, after 4 weeks & and at the end of the treatment (8 weeks).



- Tolerability will be assessed during the study. Any discontinuation of the drug will be recorded. The tab/pills consumed/unconsumed will be calculated.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-09
• Last Update Posted: 2018-11-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• 1.Men or Women, between 18 to 89 years of age (both inclusive).
• 2.Patients who have been prescribed statins OR who have had a recent increase in statin dose (in the last seven days) OR with statin intolerance and complaints of myalgia 3.Patient indication and disease condition according to the “INDICATION & USAGE†as mentioned in the package insert available with Atorsave D 4.Women of childbearing potential using an acceptable method of birth control.
• 5.Willing to give written informed consent for participation in the study and to comply with the study procedures.

Exclusion Criteria

1.Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN) 2.Creatinine phosphokinase Total (CPK-T) elevation more than 3 times the ULN 3.Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl) 4.Pregnancy 5.Malignancy 6.Contraindication as mentioned in package insert 7.Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To explore the overall safety profile of Atorsave D, as measured by adverse events and Questionnaires, in patients with hyperlipidemia or statin under conditions of routine medical practice.	Not Applicable

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (6)

Devi Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Kanoria Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Poojan Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Prisha Medical Care; 🇮🇳 Ahmadabad, GUJARAT, India

Sanjivani Super Speciality Hospitals Pvt. Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Shri Umiya Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Devi Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Kamlesh Fatania

Principal investigator

09825466788

drkamlesh_fatania@yahoo.co.in