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

NCT ID: NCT02241772

Last Updated: 2015-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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Conditions

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Elevated Lp(a)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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10mg TA-8995

10mg TA-8995 once daily

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

2.5mg TA-8995

2.5mg TA-8995 once daily

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Placebo to TA-8995

Placebo to TA-8995 once daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TA-8995

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xention Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TA-8995-06

Identifier Type: -

Identifier Source: org_study_id

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