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

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ClinicalTrials.gov Identifier: NCT02241772
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Xention Ltd

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

Condition or disease Intervention/treatment Phase
Elevated Lp(a) Drug: TA-8995 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015
Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241772


Locations
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Denmark
Herlev Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Xention Ltd
More Information
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Responsible Party: Xention Ltd
ClinicalTrials.gov Identifier: NCT02241772    
Other Study ID Numbers: TA-8995-06
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: October 2014