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
  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:


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 April 14, 2014