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

A Phase IV, Randomized, Open Label, Multicentre Study to Confirm the Safety and Tolerability of Atorsave D (Atorvastain & Cholecalciferol).

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/09/009644

Enrollment

144

Registered

2017-09-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I998- Other disorder of circulatory system Health Condition 2: null- Patients with hyperlipidemia or statin related myalgia

Interventions

Intervention1: ATORSAVE D: Atorvastatin Calcium IP eq. to Atorvastatin 10/20/40/80 mg

Cholecalciferol IP 1000 IU. Once Daily for 8 weeks. Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

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 â??INDICATION & USAGEâ?? 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

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

Design outcomes

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Primary

Measure	Time frame
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.Timepoint: Not Applicable	—

Countries

India

Contacts

Public ContactDr Hiren Gandhecha

Accutest Research Laboratories (I) Pvt Ltd

ajay.malle@accutestglobal.com02227780718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026