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NCT01069783 Clinical Trial

Study of A3309 in Patients With Dyslipidemia

Dyslipidemia Clinical Trial

Official title:
A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01069783
Other study ID # A3309-005
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2010
Est. completion date September 2010

Study information
Verified date March 2024
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• A3309
A3309 in two different dosage levels
• A3309
A3309 in two different dosage levels for the duration of the study
• Placebo
Placebo comparator once daily for the duration of the trial

Locations
Country Name City State
Sweden BCRC Linköping

Sponsors (1)
Lead Sponsor Collaborator
Albireo

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in low-density lipoprotein (LDL) cholesterol eight weeks
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