Back to resultsStudy of A3309 in Patients With Dyslipidemia
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
A3309
A3309
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring dyslipidemia, cholesterol, LDL
Eligibility Criteria
Inclusion Criteria:
- Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings
Exclusion Criteria:
- Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study
Sites / Locations
- BCRC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
A3309 low dose
A3309 high dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in low-density lipoprotein (LDL) cholesterol
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01069783
Brief Title
Study of A3309 in Patients With Dyslipidemia
Official Title
A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albireo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
dyslipidemia, cholesterol, LDL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A3309 low dose
Arm Type
Experimental
Arm Title
A3309 high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
A3309
Intervention Description
A3309 in two different dosage levels
Intervention Type
Drug
Intervention Name(s)
A3309
Intervention Description
A3309 in two different dosage levels for the duration of the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator once daily for the duration of the trial
Primary Outcome Measure Information:
Title
Change from baseline in low-density lipoprotein (LDL) cholesterol
Time Frame
eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings
Exclusion Criteria:
Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study
Facility Information:
Facility Name
BCRC
City
Linköping
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26197999
Citation
Rudling M, Camilleri M, Graffner H, Holst JJ, Rikner L. Specific inhibition of bile acid transport alters plasma lipids and GLP-1. BMC Cardiovasc Disord. 2015 Jul 22;15:75. doi: 10.1186/s12872-015-0070-9.
Results Reference
derived
Learn more about this trial
Study of A3309 in Patients With Dyslipidemia
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