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Generated: February 18, 2019

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CLINICAL TRIALS PROFILE FOR PHENTOLAMINE MESYLATE

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Clinical Trials for Phentolamine Mesylate

Trial ID Title Status Sponsor Phase Summary
NCT01422616 Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Recruiting Conselho Nacional de Desenvolvimento Científico e Tecnológico Phase 3 ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
NCT01422616 Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Recruiting Ministry for Health, Welfare and Family Affairs of the Republic of Korea Phase 3 ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
NCT01422616 Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Recruiting National Health and Medical Research Council, Australia Phase 3 ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
NCT01422616 Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Recruiting Takeda China (for the BP lowering arm of the study in China, from March 2016) Phase 3 ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
NCT01422616 Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Recruiting The Stroke Association, United Kingdom Phase 3 ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
NCT01422616 Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Recruiting The George Institute Phase 3 ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study is ongoing.
NCT01703559 The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Complaints Completed Ocularis Pharma Inc. Phase 2 Night vision complaints such as glare, starburst and halo are often a result of peripheral corneal aberrations that cause light scatter when the pupil dilates in mesopic or scotopic conditions. Modest reductions in pupil size achieved pharmacologically may reduce the light scatter in dim light situations.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Phentolamine Mesylate

Condition Name

Condition Name for Phentolamine Mesylate
Intervention Trials
Anesthesia, Local 2
Soft Tissue Anaesthesia 1
Night Vision Complaints 1
Metastatic Cancer 1
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Condition MeSH

Condition MeSH for Phentolamine Mesylate
Intervention Trials
Neoplasm Metastasis 1
Drug-Related Side Effects and Adverse Reactions 1
Cardiovascular Diseases 1
Stroke 1
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Clinical Trial Locations for Phentolamine Mesylate

Trials by Country

Trials by Country for Phentolamine Mesylate
Location Trials
United Kingdom 1
Canada 1
United States 1
China 1
Australia 1
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Trials by US State

Trials by US State for Phentolamine Mesylate
Location Trials
Arizona 1
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Clinical Trial Progress for Phentolamine Mesylate

Clinical Trial Phase

Clinical Trial Phase for Phentolamine Mesylate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Phentolamine Mesylate
Clinical Trial Phase Trials
Completed 3
Recruiting 3
Not yet recruiting 1
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Clinical Trial Sponsors for Phentolamine Mesylate

Sponsor Name

Sponsor Name for Phentolamine Mesylate
Sponsor Trials
Dalhousie University 2
Ocularis Pharma Inc. 1
León Formación 1
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Sponsor Type

Sponsor Type for Phentolamine Mesylate
Sponsor Trials
Other 12
Industry 2
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
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Fish and Richardson
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AstraZeneca
Deloitte
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