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Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

NCT02892422 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2020-10-26

Study results available
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Summary

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

Conditions

Interventions

DRUG

Lu AF35700

Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-10-10
Completion
2019-10-10

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT02892422 on ClinicalTrials.gov