HypercholesterolemiaPhase 2NCT03611010
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
A Phase 2 study testing Atorvastatin injection in people with Hypercholesterolemia and Dyslipidemias, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemias
- What is being tested?
- Atorvastatin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 24 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services
Secaucus, New Jersey, 07094
About this study
Official title: Phase II, Dose-ranging Study to Evaluate the Efficacy Dose Response and Pharmacokinetics of Intravenous Atorvastatin in Hypercholesterolemic Patients Previously Controlled With Oral Atorvastatin
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Being tested
- Atorvastatin injection
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin injectionDrug
statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Atorvastatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 15 Days
Secondary outcomes (8)
Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C
HDL-C levels were measured prior to and at the end of the 15 day treatment period to quantify the percent baseline HDL-C at 15 days. Efficacy is defined as eleven or more subjects in a dosing cohort with a Day 15 HDL-C not less than 75% of their baseline.
Measured: Baseline, 15 Days
Change in Baseline LDL-C Concentration
Mean change in LDL-C (mg/dL) from baseline at Day 15
Measured: Baseline, 15 days
Cmax IV
The maximum serum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
Measured: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Tmax IV
The time to maximum concentration of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
Measured: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
AUC 0-24
The AUC 0-24 of atorvastatin and the 2- and 4-hydroxy active metabolites following an intravenous injection to a patient at steady-state.
Measured: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
AUC Inf
The AUCinf of atorvastatin following an intravenous injection to a patient at steady-state.
Measured: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
VDss
The volume of distribution at steady state of atorvastatin following an intravenous injection to a patient.
Measured: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
t 1/2
The half-life of atorvastatin following an intravenous injection to a patient at a steady state.
Measured: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start7 Aug 2018
- Primary completion17 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Tracey, MD, Principal investigator, Frontage Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611010
- Sponsor's protocol ID
- CPI-1103-002
- Status last verified
- May 2022
- First submitted
- 19 Jul 2018
- Last updated
- 15 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Dose-ranging Study to Evaluate the Efficacy Dose Response and Pharmacokinetics of Intravenous Atorvastatin in Hypercholesterolemic Patients Previously Controlled With Oral Atorvastatin
- ClinicalTrials.gov ID
- NCT03611010
- Acronym / sponsor ID
- CPI-1103-002
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 15 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Atorvastatin injectionCohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 2 | Experimental | Drug: Atorvastatin injectionCohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 3 | Experimental | Drug: Atorvastatin injectionCohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 4 | Experimental | Drug: Atorvastatin injectionCohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin injectionstatin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C
Time frame: Baseline, 15 Days
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.
8 secondary outcomes
Efficacy, Number of Participants With Day 15 HDL-C More Than or Equal to 75% Baseline HDL-C
Time frame: Baseline, 15 Days
Change in Baseline LDL-C Concentration
Time frame: Baseline, 15 days
Cmax IV
Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Tmax IV
Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
AUC 0-24
Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
AUC Inf
Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
VDss
Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
t 1/2
Time frame: 3 to 7 minutes, 0.5h, 1h 2h, 4h, 6h, 8h, 24h post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Tracey, MD principal investigator
Frontage Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin injection in people with Hypercholesterolemia and Dyslipidemias, run by Cumberland Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C (time frame: Baseline, 15 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.