NCT02241772

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 16, 2015

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

August 20, 2014

Last Update Submit

February 12, 2015

Conditions

Elevated Lp(a)

Outcome Measures

Primary Outcomes (1)

  • To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.

    12 weeks

Secondary Outcomes (1)

  • Number of participants with adverse events

    12 weeks

Study Arms (3)

10mg TA-8995

EXPERIMENTAL

10mg TA-8995 once daily

Drug: TA-8995

2.5mg TA-8995

EXPERIMENTAL

2.5mg TA-8995 once daily

Drug: TA-8995

Placebo to TA-8995

PLACEBO COMPARATOR

Placebo to TA-8995 once daily.

Drug: Placebo

Interventions

TA-8995DRUG
10mg TA-89952.5mg TA-8995
PlaceboDRUG
Placebo to TA-8995

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Clinically significant medical history
  • Abnormal laboratory results (other than lipid levels) or vital signs
  • Receiving any other drug therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, DK-2730, Denmark

Location

MeSH Terms

Interventions

TA-8995

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

February 16, 2015

Record last verified: 2014-10

Locations

DK(1)