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Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00281320
First Posted: January 24, 2006
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Condition Intervention Phase
Psychosis Drug: Asenapine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to Day 42 (treatment period) ]
    Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).

  • Number of Participants Who Discontinued Because of an Adverse Event [ Time Frame: up to 30 days after study medication stop date ]
    Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax [ Time Frame: Day 4 or 8 ]
    Tmax defined as time to peak concentration.

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax [ Time Frame: Day 4 or 8 ]
    Cmax defined as peak concentration.

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax [ Time Frame: Day 4 or 8 ]
    dn-Cmax is defined as dose normalized peak concentration.

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin [ Time Frame: Day 4 or 8 ]
    Cmin defined as pre-dose concentration.

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12 [ Time Frame: Day 4 or 8 ]
    AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.

  • Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12 [ Time Frame: Day 4 or 8 ]
    dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.


Enrollment: 122
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 2-10 mg BID
Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)
Drug: Asenapine
Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).
Other Name: Saphris
Experimental: Asenapine 5-10mg BID
Dose titration from 5 mg to 10 mg BID
Drug: Asenapine
Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).
Other Name: Saphris

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elderly subjects with psychosis

Exclusion Criteria:

  • Have an uncontrolled, unstable clinically significant

medical condition.

  • Have an established diagnosis of dementia
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00281320     History of Changes
Other Study ID Numbers: P05717
A7501021
First Submitted: January 23, 2006
First Posted: January 24, 2006
Results First Submitted: August 12, 2010
Results First Posted: September 9, 2010
Last Update Posted: March 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs


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