CLINICAL TRIALS PROFILE FOR DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

All Clinical Trials for Diltiazem Hydrochloride In Dextrose 5%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000478 ↗	Asymptomatic Cardiac Ischemia Pilot (ACIP) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-11-01	To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.
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.
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.
NCT00007605 ↗	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	US Department of Veterans Affairs	Phase 3	1998-04-01	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.
NCT00007605 ↗	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	VA Office of Research and Development	Phase 3	1998-04-01	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.

Clinical Trial Conditions for Diltiazem Hydrochloride In Dextrose 5%

Condition Name

Condition Name for Diltiazem Hydrochloride In Dextrose 5%
Intervention	Trials
Atrial Fibrillation	12
Hypertension	10
Healthy Subjects	5
Healthy	3

Condition MeSH

Condition MeSH for Diltiazem Hydrochloride In Dextrose 5%
Intervention	Trials
Atrial Fibrillation	17
Hypertension	9
Fissure in Ano	8
Atrial Flutter	6

Clinical Trial Locations for Diltiazem Hydrochloride In Dextrose 5%

Trials by Country

Trials by Country for Diltiazem Hydrochloride In Dextrose 5%
Location	Trials
United States	150
Mexico	9
Australia	8
France	7
Germany	7

Trials by US State

Trials by US State for Diltiazem Hydrochloride In Dextrose 5%
Location	Trials
California	10
New York	7
Texas	7
North Carolina	6
Tennessee	6

Clinical Trial Progress for Diltiazem Hydrochloride In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Diltiazem Hydrochloride In Dextrose 5%
Clinical Trial Phase	Trials
Phase 4	25
Phase 3	14
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Diltiazem Hydrochloride In Dextrose 5%
Clinical Trial Phase	Trials
Completed	58
Unknown status	16
Recruiting	14

Clinical Trial Sponsors for Diltiazem Hydrochloride In Dextrose 5%

Sponsor Name

Sponsor Name for Diltiazem Hydrochloride In Dextrose 5%
Sponsor	Trials
VA Office of Research and Development	5
Ventrus Biosciences, Inc	5
AstraZeneca	4

Sponsor Type

Sponsor Type for Diltiazem Hydrochloride In Dextrose 5%
Sponsor	Trials
Other	99
Industry	39
U.S. Fed	13

Diltiazem Hydrochloride in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Diltiazem hydrochloride, a calcium channel blocker, is widely used in the management of various cardiovascular conditions, including atrial fibrillation, atrial flutter, and paroxysmal supraventricular tachycardia (PSVT). This article provides an update on the clinical trials, market analysis, and future projections for diltiazem hydrochloride in dextrose 5%.

Mechanism of Action

Diltiazem hydrochloride inhibits the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. This action reduces blood pressure, systemic vascular resistance, and the rate-pressure product, while increasing coronary blood flow[3][5].

Clinical Trials

Efficacy in Atrial Fibrillation and Atrial Flutter

Clinical trials have shown that diltiazem hydrochloride injection is effective in controlling rapid ventricular rates in atrial fibrillation and atrial flutter. In controlled trials, a 24-hour continuous infusion maintained at least a 20% heart rate reduction in 83% of patients. The heart rate reduction persisted for 0.5 to more than 10 hours after discontinuation of the infusion[1].

Paroxysmal Supraventricular Tachycardia (PSVT)

Bolus administration of diltiazem hydrochloride injection converted PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose[1].

Coronary Vasomotor Dysfunction

The EDIT-CMD trial, a double-blinded randomized placebo-controlled study, investigated the efficacy of diltiazem in improving coronary vasomotor dysfunction. While diltiazem did not substantially improve coronary vasomotor function overall, it did show a significant reduction in epicardial spasm progression to microvascular or no spasm compared to the placebo group[4].

Pharmacokinetics

Plasma Concentration and Half-Life

Diltiazem hydrochloride exhibits linear pharmacokinetics over a dose range of 10.5 to 21 mg when administered intravenously. The plasma elimination half-life is approximately 3.4 hours, with an apparent volume of distribution of about 305 L. Diltiazem is extensively metabolized in the liver with a systemic clearance of approximately 65 L/h[3][5].

Metabolism and Bioavailability

The major metabolite of diltiazem, desacetyldiltiazem, is present in the plasma at concentrations of 10% to 20% of the parent drug and is approximately 25% to 50% as potent as diltiazem. The bioavailability of diltiazem from extended-release formulations is around 41%, similar to immediate-release formulations[2].

Safety and Tolerability

Hypotension and Blood Pressure Support

In clinical trials, 3.2% of patients required intervention for blood pressure support following diltiazem hydrochloride injection, typically involving intravenous fluids or the Trendelenburg position[1].

Age and Hepatic/Renal Function

No significant differences in safety or effectiveness were observed between elderly and younger patients. However, patients with liver cirrhosis showed an increased half-life and bioavailability of diltiazem, while renal insufficiency did not affect its pharmacokinetic profile[1][2].

Market Analysis

Current Market Status

Diltiazem hydrochloride is a well-established medication in the cardiovascular market, with various formulations including immediate-release tablets, extended-release capsules, and intravenous injections. Its efficacy in managing atrial fibrillation, atrial flutter, and PSVT has made it a staple in cardiac care.

Market Trends

The global market for calcium channel blockers is expected to grow due to the increasing prevalence of cardiovascular diseases and the aging population. Diltiazem hydrochloride, with its proven track record and diverse formulations, is likely to remain a significant player in this market.

Competitive Landscape

The market for calcium channel blockers is competitive, with other drugs like verapamil and amlodipine. However, diltiazem hydrochloride's specific indications and formulations, such as the extended-release and intravenous forms, provide it with a unique market position.

Future Projections

Expanding Indications

Future clinical trials may explore additional indications for diltiazem hydrochloride, such as its potential in managing other types of arrhythmias or cardiovascular conditions. The EDIT-CMD trial's findings on coronary vasomotor dysfunction suggest potential avenues for further research.

Formulation Innovations

Advancements in drug delivery systems could lead to new formulations of diltiazem hydrochloride, enhancing patient compliance and therapeutic outcomes. For example, more sophisticated controlled-release systems could provide more consistent plasma concentrations over longer periods.

Market Growth

Given the increasing demand for effective cardiovascular treatments, the market for diltiazem hydrochloride is projected to grow. This growth will be driven by the drug's established efficacy, the expanding elderly population, and the rising incidence of cardiovascular diseases.

Key Takeaways

• Efficacy: Diltiazem hydrochloride is highly effective in managing atrial fibrillation, atrial flutter, and PSVT.
• Pharmacokinetics: It exhibits linear pharmacokinetics with a half-life of approximately 3.4 hours and is extensively metabolized in the liver.
• Safety: The drug is generally well-tolerated, though it may require blood pressure support in some cases.
• Market: The global market for calcium channel blockers is expected to grow, with diltiazem hydrochloride maintaining a significant position.
• Future Projections: Potential expansion into new indications and formulation innovations are anticipated.

FAQs

Q: What is the primary mechanism of action of diltiazem hydrochloride?

A: Diltiazem hydrochloride inhibits the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.

Q: How effective is diltiazem hydrochloride in converting PSVT to normal sinus rhythm?

A: Bolus administration of diltiazem hydrochloride injection converts PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose[1].

Q: What are the common side effects of diltiazem hydrochloride?

A: Common side effects include hypotension, which may require intervention such as intravenous fluids or the Trendelenburg position[1].

Q: Does diltiazem hydrochloride affect patients with liver cirrhosis differently?

A: Yes, patients with liver cirrhosis show an increased half-life and bioavailability of diltiazem[2].

Q: What is the projected market growth for diltiazem hydrochloride?

A: The market for diltiazem hydrochloride is expected to grow due to the increasing prevalence of cardiovascular diseases and the aging population.

Sources

1. Pfizer Medical Information - US: Diltiazem Hydrochloride for Injection.
2. Accessdata.fda.gov: Dilacor XR - diltiazem hydrochloride capsule, extended release.
3. Pfizer Labeling: Diltiazem Hydrochloride Injection.
4. Journal of the American College of Cardiology: Efficacy of Diltiazem to Improve Coronary Vasomotor Dysfunction in Patients with ANOCA.
5. Health Canada: Product Monograph Pr Diltiazem Hydrochloride Injection.