- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161082
Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
January 24, 2015 updated by: Regeneron Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single to Multi-Dose Study of Safety, Tolerability, and Bioeffect of Subcutaneously Administered REGN727 in Patients With and Without Concomitant Atorvastatin
This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy.
The study drug and placebo will be administered by subcutaneous injection at the clinic.
There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period).
Patients on atorvastatin will take their daily dose in the morning for the duration of the study.
Patients will be monitored by the study staff for side effects and the body's response to the study drug.
Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.
Study Overview
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States
- Site 1
-
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Tennessee
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Knoxville, Tennessee, United States
- Site 2
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen
- Body mass index between 18.0 and 35.0 kg/m2, inclusive
- For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day -2 or day -1
- For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant)during the full duration of the study
- Willing, committed and able to return for all the clinic visits and complete all study-related procedures
- Able to read, and able to sign the informed consent form
Exclusion Criteria:
- History of MI, ACS, Angina, Stroke, peripheral vascular disease, or cardiac revascularization
- Pregnant or breast-feeding women
- Blood donation of any volume within 1 month prior to administration of study drug
- Congestive heart failure
- Consumption of greater than 1 quart of grapefruit juice per day
- Previous exposure to any therapeutic or investigational biological agent within 30 days of screening
- History of alcohol or drug abuse within one year to the screening visit
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 with atorvastatin
Dose 1 versus placebo
|
subcutaneous
|
Experimental: Group 2 with atorvastatin
Dose 1 versus placebo
|
subcutaneous
|
Experimental: Group 3 with atorvastatin
Dose 2 versus placebo
|
subcutaneous
|
Experimental: Group 4 with atorvastatin
Dose 2 versus placebo
|
subcutaneous
|
Experimental: Group 5 with atorvastatin
Dose 3 versus placebo
|
subcutaneous
|
Experimental: Group 6 with atorvastatin
Dose 3 versus placebo
|
subcutaneous
|
Experimental: Group 7 without atorvastatin
Dose 3 versus placebo
|
subcutaneous
|
Experimental: Group 8 with atorvastatin
Dose4 versus placebo
|
subcutaneous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.
Time Frame: visit 4 (day 1) to visit 16 (day 148)
|
visit 4 (day 1) to visit 16 (day 148)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
Time Frame: Visit 4 (Day 1) to Visit 16 (Day 148)
|
Visit 4 (Day 1) to Visit 16 (Day 148)
|
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
Time Frame: Visit 4 (Day 1) to Visit 16 (Day 148)
|
Visit 4 (Day 1) to Visit 16 (Day 148)
|
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin
Time Frame: Visit 4 (Day 1) to Visit 16 (Day 148)
|
Visit 4 (Day 1) to Visit 16 (Day 148)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gary Swergold, MD, PhD, Regeneron Pharmaceuticals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
July 9, 2010
First Submitted That Met QC Criteria
July 9, 2010
First Posted (Estimate)
July 13, 2010
Study Record Updates
Last Update Posted (Estimate)
January 27, 2015
Last Update Submitted That Met QC Criteria
January 24, 2015
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R727-CL-1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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