A Study on the Effects of TA-8995 on Lp(a) in Subjects Wi... | NCT02241772

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

NCT02241772

Sponsor

Xention Ltd

Status

Completed

Last Update Posted

Feb 16, 2015Estimated

Enrollment

42Actual

Phase

Phase 1Phase 2

Conditions

Elevated Lp(a)

Interventions

TA-8995
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Aug 20, 2014

First Submission Date that Met QC Criteria

Sep 12, 2014

First Posted Date

Sep 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2015

Last Update Posted Date

Feb 16, 2015Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
TA-8995	Drug		10mg TA-8995 2.5mg TA-8995
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev Hospital		Herlev		DK-2730	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
C000597751	TA-8995

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided