40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00159783
First received: September 8, 2005
Last updated: April 30, 2014
Last verified: April 2014

September 8, 2005
April 30, 2014
July 2005
March 2007   (final data collection date for primary outcome measure)
  • Participants Who Experienced Adverse Event(s) [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]

    Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug.

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment.

    An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

  • Number of Participants With Abnormal Physical Examination Findings [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]
    Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm & rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
  • Number of Participants With Abnormal Electrocardiogram [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]
    This is the number of participants with electrocardiogram (ECG) adverse events.
  • Body Weight [ Time Frame: Baseline to Week 40 or endpoint ] [ Designated as safety issue: Yes ]
    Weight change from baseline
  • Extrapyramidal Symptoms [EPS] [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]

    EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS.

    AIMS score range 0-4; higher scores indicate greater symptom severity.

    BARS score rang 0-9; higher scores indicate greater severity of akathisia.

    SARS score range 0-40; higher scores indicate greater degree of Parkinsonism.

  • Concomitant Medications [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]

    Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of

    last dose of double-blind study drug.

  • Abdominal Girth [ Time Frame: Baseline to Week 40 or endpoint ] [ Designated as safety issue: Yes ]
    Change in abdominal girth from baseline
  • Number of Participants With Markedly Abnormal Vital Sign Changes [ Time Frame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint) ] [ Designated as safety issue: Yes ]

    Vital signs measured: sitting blood pressure, heart rate.

    Definitions:

    Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.

    Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg.

  • Number of Participants With Laboratory Values Outside Normal Range [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]

    Normal ranges were provided by the central laboratory.

    Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin

    Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin

    Endocrinology/miscellaneous = insulin, prolactin

    Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils

Improvement in bipolar manic or mixed episodes
Complete list of historical versions of study NCT00159783 on ClinicalTrials.gov Archive Site
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40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)

Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: asenapine
    Asenapine, 40 weeks
    Other Name: Org 5222
  • Drug: Olanzapine
    Olanzapine, 40 weeks
  • Experimental: Asenapine
    Asenapine 5-10 mg twice daily for 40 weeks
    Intervention: Drug: asenapine
  • Active Comparator: Olanzapine
    Olanzapine 5-20 mg once daily for 40 weeks
    Intervention: Drug: Olanzapine
McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
April 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

Exclusion Criteria:

  • Patients with unstable medical conditions or clinically significant laboratory

abnormalities.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00159783
P05857, A7501007
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Not Provided
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP