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A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males

NCT02781311 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2019-04-05

Study results available
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Summary

This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA).

Conditions

Interventions

DRUG

Setipiprant

Setipiprant tablets, orally, BID for 24 weeks.

DRUG

Placebo

Placebo tablets, orally, BID for 24 weeks.

DRUG

Finasteride

Finasteride tablet, orally, once daily for 24 weeks.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Joan-En Lin · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-14
Primary Completion
2018-03-15
Completion
2018-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781311 on ClinicalTrials.gov