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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR VERAPAMIL HYDROCHLORIDE


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505(b)(2) Clinical Trials for VERAPAMIL HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT04489134 ↗ P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release Not yet recruiting Rennes University Hospital Phase 2 2021-11-01 Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named LCP-Tacro (Envarsus®), formulated using the Melt-Dose process. Tacrolimus is a lipophilic macrolide drug able to passive transmembrane diffusion. Its bioavailability displays a large interindividual variability, from 9 to 43%. Indeed, tacrolimus is a substrate of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4). P-gp is an efflux protein mainly located at the apex of the epithelia of the intestine, lymphocyte, kidney and blood-brain barrier. P-gp therefore limits the intestinal resorption of tacrolimus and also its diffusion into its target compartment (i.e the lymphocyte. The expression of this protein is different throughout the digestive tract with maximum expression at the ileal level. CYP3A4 is a coenzyme that is responsible of more than 90% of the metabolism of tacrolimus, at the digestive and hepatic level. Both P-gp and CYP3A4 play a role in tacrolimus absorption/diffusion process. A new formulation of tacrolimus, LCP-Tacro, (Envarsus®) was approved in 2014. Its efficacy was compared to Prograf® in two phase III de novo or switch Prograf® trials in kidney transplantation. With tacrolimus, there is a strong inter-individual pharmacokinetic variability which, to date, has not been fully characterized. Variations in bioavailability may partly explain this high variability. The different formulations are resorbed at distinct gastrointestinal sites which could explain different absorptions between Prograf/Advagraf and LCP-Tacro forms. These findings raise the question of the role of P-gp in explaining the difference in bioavailability between formulations. The use of a P-gp inhibitor could therefore have a different impact on exposure to different galenic formulations. Verapamil is an inhibitor of P-gp and CYP 3A4, which is frequently prescribed and recommended by FDA for drug-drug interaction studies aiming at evaluating P-gp substrates, used in healthy volunteers at dosages up to 240 mg/D13-14. Otherwise, verapamil-tacrolimus interaction has been characterized in vitro. It has also been shown that inhibitory effect of verapamil at a single dose of 120 mg administered one hour prior to the administration of a P-gp substrate exhibited an optimum power of inhibition. The safety of Advagraf® and Envarsus® administrations have already been subjected to several phase I trials in healthy volunteers reinforcing the knowledge of their safety profile. The aim of the study is to compare the interaction profile of Advagraf® and Envarsus® when co-administered with verapamil in healthy subjects and to provide guidelines on tacrolimus dosage adjustment in such cases.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for VERAPAMIL HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000556 ↗ Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1995-03-01 To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.
NCT00001302 ↗ A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833 Completed National Cancer Institute (NCI) Phase 1 1992-09-01 The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.
NCT00001383 ↗ A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833 Completed National Cancer Institute (NCI) Phase 1 1994-03-01 This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses. Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed US Department of Veterans Affairs 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed VA Office of Research and Development 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for VERAPAMIL HYDROCHLORIDE

Condition Name

Condition Name for VERAPAMIL HYDROCHLORIDE
Intervention Trials
Healthy 11
Atrial Fibrillation 6
Hypertension 5
Diabetes 5
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Condition MeSH

Condition MeSH for VERAPAMIL HYDROCHLORIDE
Intervention Trials
Atrial Fibrillation 10
Diabetes Mellitus 8
Hypertension 7
Coronary Artery Disease 6
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Clinical Trial Locations for VERAPAMIL HYDROCHLORIDE

Trials by Country

Trials by Country for VERAPAMIL HYDROCHLORIDE
Location Trials
United States 135
United Kingdom 11
Canada 11
Netherlands 10
France 9
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Trials by US State

Trials by US State for VERAPAMIL HYDROCHLORIDE
Location Trials
California 10
New York 7
Minnesota 7
Massachusetts 6
Pennsylvania 6
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Clinical Trial Progress for VERAPAMIL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for VERAPAMIL HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 33
Phase 3 13
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for VERAPAMIL HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 82
Recruiting 20
Unknown status 19
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Clinical Trial Sponsors for VERAPAMIL HYDROCHLORIDE

Sponsor Name

Sponsor Name for VERAPAMIL HYDROCHLORIDE
Sponsor Trials
VA Office of Research and Development 5
AstraZeneca 5
Mylan Pharmaceuticals 4
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Sponsor Type

Sponsor Type for VERAPAMIL HYDROCHLORIDE
Sponsor Trials
Other 179
Industry 45
U.S. Fed 13
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