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

February 12, 2015 updated by: Xention Ltd
A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, DK-2730
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10mg TA-8995
10mg TA-8995 once daily
Drug: TA-8995
Experimental: 2.5mg TA-8995
2.5mg TA-8995 once daily
Drug: TA-8995
Placebo Comparator: Placebo to TA-8995
Placebo to TA-8995 once daily.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xention Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • TA-8995-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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