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Last Updated: May 14, 2021

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CLINICAL TRIALS PROFILE FOR BROMOCRIPTINE MESYLATE

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All Clinical Trials for BROMOCRIPTINE MESYLATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00377676 Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes Completed VeroScience Phase 3 2004-07-01 Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well.
NCT00649168 Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg Completed Mylan Pharmaceuticals Phase 1 2007-04-01 The objective of this study was to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine mesylate capsules, following the administration of a 10 mg dose, under fed conditions.
NCT00650520 Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets Completed Mylan Pharmaceuticals Phase 1 2007-05-01 The objective of this study is to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed conditions.
NCT02078440 Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects Completed VeroScience Phase 1 2014-01-01 The objective of this study is to evaluate the relative bioavailability, and the rate and extent of absorption of bromocriptine in male and female children and adolescent Type 2 Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions. It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes children aged 10- to less than 18 years differs appreciably from that in healthy adults. Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children have demonstrated little difference in clearance among children over 10 years of age compared to adults (Blanco et al, 2000). However, differences in blood volumes or other factors may impart differences that could affect the pharmacokinetic properties of bromocriptine-QR. Therefore, this study will assess the pharmacokinetics in children aged 10-to less than 18 years who have type 2 diabetes. After describing the profile of bromocriptine-quick release in this patient population, a follow on study will be conducted to evaluate its safety and efficacy in treating children and adolescents who have type 2 diabetes. The pharmacokinetic profile of bromocriptine will be determined following the administration of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study will be a single period, bioavailability study in 30 patients. The study duration will be 3 days.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BROMOCRIPTINE MESYLATE

Condition Name

Condition Name for BROMOCRIPTINE MESYLATE
Intervention Trials
Healthy 2
Type 2 Diabetes Mellitus 1
Type 2 Diabetes 1
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Condition MeSH

Condition MeSH for BROMOCRIPTINE MESYLATE
Intervention Trials
Diabetes Mellitus 2
Diabetes Mellitus, Type 2 2
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Clinical Trial Locations for BROMOCRIPTINE MESYLATE

Trials by Country

Trials by Country for BROMOCRIPTINE MESYLATE
Location Trials
United States 5
Canada 2
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Trials by US State

Trials by US State for BROMOCRIPTINE MESYLATE
Location Trials
Missouri 1
Florida 1
Connecticut 1
Arizona 1
Pennsylvania 1
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Clinical Trial Progress for BROMOCRIPTINE MESYLATE

Clinical Trial Phase

Clinical Trial Phase for BROMOCRIPTINE MESYLATE
Clinical Trial Phase Trials
Phase 3 1
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for BROMOCRIPTINE MESYLATE
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for BROMOCRIPTINE MESYLATE

Sponsor Name

Sponsor Name for BROMOCRIPTINE MESYLATE
Sponsor Trials
VeroScience 2
Mylan Pharmaceuticals 2
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Sponsor Type

Sponsor Type for BROMOCRIPTINE MESYLATE
Sponsor Trials
Industry 4
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Serving leading biopharmaceutical companies globally:

Merck
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McKinsey
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AstraZeneca
Boehringer Ingelheim

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