Skip to content

Observational disease registry study to collect the data on management of LDL-Cholesterol for patients receiving lipid-modifying treatments in real-life

International, cross-sectional, non-interventional, disease observational study to describe the management and the LDL-Cholesterol control versus ESC/EAS guidelines of patients receiving lipid-modifying treatments in non-US non-European countries in real-life

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/11/016373
Enrollment
9159
Registered
2018-11-16
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: null- hypercholesterolaemia

Interventions

None listed

Sponsors

Sanofi Synthelabo India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient receiving a lipid-modifying therapy for atleast 3 months with a LDL-C value performed less than 12 months AND under the same lipid-modifying treatment (same drugs, same doses) received for at least 3 months at the time of sample 2. Patient agrees to participate in the study by giving written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patient currently participating in a clinical trial 2.Past use of a PCSK9 inhibitor within 6 months prior to study entry

Design outcomes

Primary

MeasureTime frame
Percentage of patients reaching LDL-C targets as defined by the ESC/EAS guidelines for the management of dyslipidemia (2011), in patients at very high, high and moderate CV risk.Timepoint: Visit 1 As this is a cross sectional study with no follow-ups.

Secondary

MeasureTime frame
1.Percentage of patients reaching LDL-C targets as defined by the ESC/EAS guidelines for the management of dyslipidemia (2011), by physiciansâ?? specialty 2.Description of Patientâ??s profiles 3.Investigatorâ??s assessment of LDL-C target and patientâ??s level of CV risk 4. Patients at the maximum tolerated dose of statin 5.Physicianâ??s characteristics 6.Health-care resourcesâ?? consumptioTimepoint: Visit 1. since this is a cross-sectional study with only one visit and no follow-ups hence all assessments will be done in the first visit.

Countries

Algeria, Argentina, Bangladesh, Brazil, Colombia, Israel, Kuwait, Lebanon, Mexico

Contacts

Public ContactMr Raviteja Adapa

Sanofi Synthelabo India Limited

Raviteja.adapa@sanofi.com02228032000

Outcome results

None listed

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