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Study of A3309 in Patients With Dyslipidemia

This study has been completed.
Sponsor:
Information provided by:
Albireo
ClinicalTrials.gov Identifier:
NCT01069783
First received: February 16, 2010
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).


Condition Intervention Phase
Dyslipidemia
 Drug: A3309
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Albireo:

Primary Outcome Measures:
  • Change from baseline in low-density lipoprotein (LDL) cholesterol [ Time Frame: eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A3309 low dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Experimental: A3309 high dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator once daily for the duration of the trial

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069783

Locations
Sweden
BCRC
Linköping, Sweden
Sponsors and Collaborators
Albireo
  More Information

No publications provided

Responsible Party: Hans Graffner, MD, Albireo
ClinicalTrials.gov Identifier: NCT01069783     History of Changes
Other Study ID Numbers: A3309-005
Study First Received: February 16, 2010
Last Updated: October 19, 2010
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Albireo:
dyslipidemia
cholesterol
LDL

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013