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NCT03611010 · ClinicalTrials.gov registry record · Phase 2

Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients

A Phase 2 study, sponsored by Cumberland Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT03611010: Completed Phase 2 study, sponsored by Cumberland Pharmaceuticals.

NCT03611010 is a Phase 2 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03611010, a Phase 2 study, has completed, sponsored by Cumberland Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.

Primary Outcome

LDL-C levels were measured prior to and at the end of the 15 day treatment period to quantify the percent baseline LDL-C at 15 days. Efficacy is defined as eleven or more subjects in a dosing cohort with a Day 15 LDL-C not more than 125% of their baseline.

Interventions

  • DRUG Atorvastatin injection

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-08-07
Est. Completion 2020-02-24
Phase Phase 2
Cumberland Pharmaceuticals

43 total trials

What the finished NCT03611010 record still lists

NCT03611010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which Atorvastatin injection is the first listed.

NCT03611010 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03611010 about?

NCT03611010 is a clinical study titled "Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients". Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.

What is the current status of trial NCT03611010?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-08-07. Estimated completion is 2020-02-24.

What interventions are being tested in trial NCT03611010?

The interventions under investigation include: Atorvastatin injection (DRUG).

Who is sponsoring clinical trial NCT03611010?

This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03611010's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03611010, the US trial registry maintained by the National Library of Medicine. NCT03611010 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.