Phase 2
Completed N=40
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Hypercholesterolemia · Dyslipidemias
Source: ClinicalTrials.gov NCT03611010 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C — 9; 9; 1; 7 Participants
Summary
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C |
9; 9; 1; 7 | — |
| SECONDARY Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C |
11; 13; 1; 9 | — |
| SECONDARY Change in Baseline LDL-C Concentration |
12.36; 2.62; 27.50; 11.22 | — |
| SECONDARY Cmax IV |
284.33; 830.34; 507.50; 0.40; 1.23; 3.23 | — |
| SECONDARY Tmax IV |
0.08; 0.08; 0.15; 6.00; 6.0; 5.00 | — |
| SECONDARY AUC 0-24 |
72.12; 137.04; 212.00; 3.35; 16.76; 49.20 | — |
| SECONDARY AUC Inf |
72.19; 167.32; 217.00 | — |
| SECONDARY VDss |
71.86; 135.53; 182.85 | — |
| SECONDARY t 1/2 |
4.79; 6.22; 6.38 | — |
Eligibility Criteria
Inclusion Criteria
- On stable dose of daily oral atorvastatin for >= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin)
- Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.
Exclusion Criteria
- History of myopathy or rhabdomyolysis
- Liver disease including current biliary disorders
- Positive for HIV, Hepatitis B or Hepatitis C Virus
- Abuse of alcohol or non-prescribed drugs
- Unstable angina or arrhythmias or a cardiac event in the previous three months
- hypothyroidism, diabetes, or hypertension that is not under control
- pregnant or plans to be pregnant
Data sourced from ClinicalTrials.gov (NCT03611010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.