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| ID | Type | Description | Link |
|---|---|---|---|
| A7501007 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine | Experimental | Asenapine 5-10 mg twice daily for 40 weeks |
|
| Olanzapine | Active Comparator | Olanzapine 5-20 mg once daily for 40 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine | Drug | Asenapine, 40 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Experienced Adverse Event(s) | 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. | Up to 40 weeks |
| Number of Participants With Abnormal Physical Examination Findings | 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. | Week 40 or endpoint |
| Number of Participants With Abnormal Electrocardiogram | This is the number of participants with electrocardiogram (ECG) adverse events. | Week 40 or endpoint |
| Body Weight | Weight change from baseline | Baseline to Week 40 or endpoint |
| Extrapyramidal Symptoms [EPS] | 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. | Week 40 or endpoint |
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Inclusion Criteria:
Exclusion Criteria:
abnormalities.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20537396 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Asenapine | Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study) |
| FG001 | Asenapine | Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study) |
| FG002 | Olanzapine | Olanzapine 5-20 mg once daily for 40 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Asenapine | Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study) |
| BG001 | Asenapine | Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Who Experienced Adverse Event(s) | 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. | Posted | Number | Participants | Up to 40 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Asenapine | Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Olanzapine | Drug | Olanzapine, 40 weeks |
|
| Concomitant Medications | 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. | Up to 40 weeks |
| Abdominal Girth | Change in abdominal girth from baseline | Baseline to Week 40 or endpoint |
| Number of Participants With Markedly Abnormal Vital Sign Changes | 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. | Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint) |
| Number of Participants With Laboratory Values Outside Normal Range | 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 | Week 40 or endpoint |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| BG002 | Olanzapine | Olanzapine 5-20 mg once daily for 40 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Asenapine |
Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study) |
| OG002 | Olanzapine | Olanzapine 5-20 mg once daily for 40 weeks |
|
|
| Primary | Number of Participants With Abnormal Physical Examination Findings | 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. | Posted | Number | Participants | Week 40 or endpoint |
|
|
|
| Primary | Number of Participants With Abnormal Electrocardiogram | This is the number of participants with electrocardiogram (ECG) adverse events. | Posted | Number | Participants | Week 40 or endpoint |
|
|
|
| Primary | Body Weight | Weight change from baseline | Posted | Mean | Standard Deviation | Kilograms | Baseline to Week 40 or endpoint |
|
|
|
| Primary | Extrapyramidal Symptoms [EPS] | 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. | Posted | Mean | Standard Deviation | Units on a scale | Week 40 or endpoint |
|
|
|
| Primary | Concomitant Medications | 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. | Posted | Number | Participants | Up to 40 weeks |
|
|
|
| Primary | Abdominal Girth | Change in abdominal girth from baseline | Posted | Mean | Standard Deviation | Centimeters (cm) | Baseline to Week 40 or endpoint |
|
|
|
| Primary | Number of Participants With Markedly Abnormal Vital Sign Changes | 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. | Posted | Number | Participants | Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint) |
|
|
|
| Primary | Number of Participants With Laboratory Values Outside Normal Range | 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 | Number at risk = participants with either normal or abnormal baseline value and a non-missing value at endpoint. Actual at risk: 20-32 for placebo/asenapine arm; 50-78 for asenapine arm; 63-106 in olanzapine arm. | Posted | Number | Participants | Week 40 or endpoint |
|
|
|
| 2 |
| 32 |
| 12 |
| 32 |
| EG001 | Asenapine | Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study) | 6 | 79 | 28 | 79 |
| EG002 | Olanzapine | Olanzapine 5-20 mg once daily for 40 weeks | 9 | 107 | 34 | 107 |
| Death neonatal | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
If study is part of a multicenter trial, Investigator agrees that the first publication is to be a joint publication covering all centers. However, if a joint manuscript has not been submitted for publication within 12 mos of completion or termination of study at all participating sites, Investigator is free to publish separately.
The sponsor should review any publication prior to submission for publication to ensure no confidential information is released inadvertently.
| D006571 | Heterocyclic Compounds |
|
| ECG QRS complex prolonged |
|
| ECG ST segment depression |
|
| ECG T wave inversion |
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| Supraventricular extrasystoles |
|
| Ventricular extrasystoles |
|
|
|
| SARS |
|
|
|
| Title | Measurements |
|---|---|
|
| Endocrinology/miscellaneous |
|
| Hematology |
|