➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Boehringer Ingelheim
AstraZeneca
Colorcon
Moodys

Last Updated: August 10, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR ASENAPINE

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

All Clinical Trials for Asenapine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00143182 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED) Completed Pfizer Phase 3 2005-01-01 Bipolar disorder is characterized by mood swings that range 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 the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.
NCT00143182 9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2005-01-01 Bipolar disorder is characterized by mood swings that range 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 the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.
NCT00145470 12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008)(COMPLETED)(P05844) Completed Merck Sharp & Dohme Corp. Phase 3 2005-06-01 This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
NCT00145496 Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771) Completed Merck Sharp & Dohme Corp. Phase 3 2004-12-01 Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
NCT00145509 40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786) Completed Merck Sharp & Dohme Corp. Phase 3 2005-08-01 The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Asenapine

Condition Name

Condition Name for Asenapine
Intervention Trials
Schizophrenia 26
Bipolar Disorder 13
Schizoaffective Disorder 5
Bipolar I Disorder 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Asenapine
Intervention Trials
Schizophrenia 29
Bipolar Disorder 16
Disease 15
Psychotic Disorders 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Asenapine

Trials by Country

Trials by Country for Asenapine
Location Trials
United States 56
Spain 9
India 7
Canada 4
Russian Federation 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Asenapine
Location Trials
Ohio 6
New York 5
Georgia 4
California 4
Texas 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Asenapine

Clinical Trial Phase

Clinical Trial Phase for Asenapine
Clinical Trial Phase Trials
Phase 4 11
Phase 3 35
Phase 2/Phase 3 1
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Asenapine
Clinical Trial Phase Trials
Completed 42
Recruiting 8
Unknown status 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Asenapine

Sponsor Name

Sponsor Name for Asenapine
Sponsor Trials
Merck Sharp & Dohme Corp. 37
Forest Laboratories 4
Pfizer 4
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Asenapine
Sponsor Trials
Industry 56
Other 20
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Merck
AstraZeneca
Dow
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.