A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)

Elevated Lp(a) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241772
• Other study ID #: TA-8995-06
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 20, 2014
• Last updated: February 12, 2015
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2014
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels

Exclusion Criteria:

• Clinically significant medical history

• Abnormal laboratory results (other than lipid levels) or vital signs

• Receiving any other drug therapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elevated Lp(a)

Intervention

Drug:
• TA-8995

• Placebo

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Xention Ltd

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.		12 weeks	Yes
Secondary	Number of participants with adverse events		12 weeks	Yes