Hypercholesterolemia
Conditions
Brief summary
Percent change from baseline in LDL-C levels at day 150
Detailed description
Percent change from baseline in LDL-C levels at day 150, Individual responsiveness of participants defined through on treatment LDL-C levels of < 55 mg/dL (very high-risk subjects) and < 70 mg/dL (high risk subjects) at Day 150, Absolute change from Baseline in LDL-C at day 150, Percent change from baseline in LDL-C levels between Day 30 up to Day 150, Percent change from baseline in LDL-C levels between Day 90 and Day 150, Mean change from BL in MMAS-8 over time, Mean change from BL in TSQM over time, Mean change from BL in SF-BPI over time, Proportion of participants with clinically significant change from BL [MCID of 2 points] in SF-BPI at Day 150
Interventions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in LDL-C levels at day 150 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in LDL-C levels at day 150, Individual responsiveness of participants defined through on treatment LDL-C levels of < 55 mg/dL (very high-risk subjects) and < 70 mg/dL (high risk subjects) at Day 150, Absolute change from Baseline in LDL-C at day 150, Percent change from baseline in LDL-C levels between Day 30 up to Day 150, Percent change from baseline in LDL-C levels between Day 90 and Day 150, Mean change from BL in MMAS-8 over time, Mean change from BL in TSQM over time, Mean change from BL in SF-BPI over time, Proportion of participants with clinically significant change from BL [MCID of 2 points] in SF-BPI at Day 150 | — |
Countries
Germany
Outcome results
None listed