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Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

NCT01377233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-03-22

Study results available
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Summary

The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.

Conditions

Interventions

DRUG

Zicronapine open-label lead-in 10 mg daily

Encapsulated tablet ,10 mg, once daily, open-label

DRUG

Zicronapine 10 mg daily

Encapsulated tablet, 10 mg, once daily, double-blind

DRUG

Zicronapine 20 mg once weekly

Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind

DRUG

Zicronapine 30 mg once weekly

Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind

DRUG

Zicronapine 45 mg once weekly

Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29

Countries

  • United States

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 NCT01377233 on ClinicalTrials.gov