NCT03611010

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

July 19, 2018

Results QC Date

May 3, 2022

Last Update Submit

June 22, 2022

Conditions

HypercholesterolemiaDyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C

    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.

    Baseline, 15 Days

Secondary Outcomes (8)

  • Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C

    Baseline, 15 Days

  • Change in Baseline LDL-C Concentration

    Baseline, 15 days

  • Cmax IV

    3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose

  • Tmax IV

    3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose

  • AUC 0-24

    3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose

  • +3 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Drug: Atorvastatin injection

Cohort 2

EXPERIMENTAL

Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Drug: Atorvastatin injection

Cohort 3

EXPERIMENTAL

Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Drug: Atorvastatin injection

Cohort 4

EXPERIMENTAL

Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days

Drug: Atorvastatin injection

Interventions

Atorvastatin injectionDRUG

statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frontage Clinical Services

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Senior Manager, Clinical Development
Organization
Cumberland Pharmaceuticals Inc.
imaciasperez@cumberlandpharma.com
6155642188

Study Officials

  • Gregory Tracey, MD

    Frontage Lab

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 2, 2018

Study Start

August 7, 2018

Primary Completion

February 17, 2020

Study Completion

February 24, 2020

Last Updated

July 15, 2022

Results First Posted

July 15, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)