CLINICAL TRIALS PROFILE FOR DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

All Clinical Trials for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

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.
NCT00039975 ↗	Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	Diltiazem CD and amlodipine are drugs used to treat heart disease and high blood pressure. The purpose of this study is to find out if these drugs interact with the anti-HIV drugs indinavir and ritonavir. The study will also look at the safety of taking the study drugs together. Heart disease and high blood pressure are major health concerns for people with HIV. Standard treatment for these illnesses often includes calcium channel blockers (CCBs). There is a potential for significant drug interactions between CCBs and HIV protease inhibitors (PIs) that may influence the dosing, monitoring, and choosing of CCBs and PIs when used in people infected with HIV. This study will examine the drug interactions between 2 commonly used CCBs and the PI combination indinavir and ritonavir (IDV/RTV). This information should help doctors choose the appropriate treatment for high blood pressure or heart disease in people taking PIs.

Clinical Trial Conditions for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Condition Name

Condition Name for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Intervention	Trials
Atrial Fibrillation	13
Hypertension	10
Healthy	8
Healthy Subjects	5

Condition MeSH

Condition MeSH for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Intervention	Trials
Atrial Fibrillation	18
Hypertension	9
Fissure in Ano	8
Atrial Flutter	7

Clinical Trial Locations for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Trials by Country

Trials by Country for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Location	Trials
United States	157
Mexico	9
Australia	8
France	7
Germany	7

Trials by US State

Trials by US State for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Location	Trials
California	10
New York	7
Texas	7
Tennessee	7
North Carolina	6

Clinical Trial Progress for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE1	6

Clinical Trial Status

Clinical Trial Status for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Clinical Trial Phase	Trials
COMPLETED	66
Unknown status	16
Recruiting	15

Clinical Trial Sponsors for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Sponsor	Trials
Merck Sharp & Dohme LLC	6
Ventrus Biosciences, Inc	5
VA Office of Research and Development	5

Sponsor Type

Sponsor Type for DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
Sponsor	Trials
Other	104
Industry	45
U.S. Fed	13

Last updated: May 15, 2026

Diltiazem Hydrochloride in 0.72% Sodium Chloride: Clinical Trials Update, Market Analysis, and Exclusivity/Generic Outlook

Executive summary: A “diltiazem hydrochloride in 0.72% sodium chloride” product is an IV infusion formulation used for rate control in acute settings (eg, atrial fibrillation/flutter with rapid ventricular response). Public clinical-trials, FDA regulatory, and patent-exclusivity visibility for this exact strength and diluent combination is limited in open sources versus broader “diltiazem hydrochloride IV” indications and product families. Market sizing and forecast depend on (i) whether this exact product is FDA-approved as a distinct NDC/labeling construct and (ii) whether it is sold as branded, authorized generic, or compounded hospital stock. Without product-level FDA/NDC and trial identifiers, a complete, accuracy-safe market and pipeline projection cannot be produced.

Clinical trials update: What trials exist for diltiazem hydrochloride IV in 0.72% sodium chloride?

Featured-snippet answer: No complete, accuracy-safe update can be provided at the level of “diltiazem hydrochloride in 0.72% sodium chloride” because open trial registries and publications typically index the active ingredient as diltiazem hydrochloride (IV) without consistently specifying the 0.72% sodium chloride diluent in trial metadata.

How are diltiazem IV trials usually indexed?

• Trial records commonly list comparator regimens as diltiazem infusion vs alternative rate-control agents (commonly beta-blockers, amiodarone in certain settings, or placebo in pharmacodynamic studies).
• Many clinical papers report “diltiazem IV” dosing schedules, sometimes describing infusion preparation generically (diluent may be hospital-specific or pharmacy-prepared), which prevents mapping trial results to this exact combination.

What endpoints matter for adoption in acute rate control?

• Time to ventricular rate control (eg, target HR achieved within a defined window).
• Safety endpoints: hypotension, bradycardia, heart block, worsening heart failure, infusion-site reactions.
• Practical adoption endpoints: protocol adherence, need for rescue meds, nursing workload, and compatibility constraints.

What this means for a “0.72% sodium chloride” pipeline read-through

• Without a trail of registries/publications that explicitly bind the diluent choice to the regimen, pipeline statements would risk mixing evidence across different commercially prepared diluents and compounding practices.

Market analysis: How big is the market for diltiazem hydrochloride IV infusions?

Featured-snippet answer: A market analysis cannot be quantified to this exact formulation without confirmed FDA commercial availability by NDC and labeling. In the absence of product-level identifiers, any market size or share projections would mix multiple diltiazem IV presentations (different strengths, diluents, package sizes, and authorized-generic status).

Market structure that drives forecast accuracy

• Acute-care consumption is influenced by:
  • Hospital formularies and standard rate-control order sets.
  • Concentration and stability preferences used in pharmacy compounding or premix purchasing.
  • Short product lifecycles for premix SKUs when supply constraints change.

Commercial drivers for IV diltiazem

• High-volume ED and inpatient management of AFib/Aflutter with RVR.
• Guideline-concordant use in patients where beta-blocker strategy is unsuitable.
• Logistics and nursing workflow benefits if a premixed product reduces pharmacy preparation time.

Commercial constraints

• Compatibility and preparation rules can force compounding even when a premix exists, eroding share.
• Competition from alternative IV rate-control products can limit incremental demand.

Revenue projection: When will demand shift for diltiazem hydrochloride IV?

Featured-snippet answer: Demand shift timing cannot be projected specifically for “0.72% sodium chloride premix” without (i) confirmed launch history or discontinuations by NDC and (ii) evidence that clinical protocol changes mandate that exact diluent.

Typical timing triggers investors model for IV injectables

• New guideline updates or formulary wins that broaden IV use.
• Tender cycles and hospital contracting changes for premix vs compounded stock.
• Generic/authorized-generic availability that compresses gross-to-net margins.
• Supply continuity events that cause temporary substitution across brands.

Exclusivity and generic risk: What patents protect diltiazem hydrochloride IV and when do they expire?

Featured-snippet answer: A formulation-specific exclusivity and patent-expiration map for “diltiazem hydrochloride in 0.72% sodium chloride” cannot be produced without an FDA Orange Book linkage to the exact NDC/strength/package combination.

Why the NDC matters for exclusivity

• Patent listings attach to specific NDA/ANDA products, not necessarily to a diluent-level description.
• Different presentations can share active-ingredient IP but differ in:
  • formulation/process claims
  • packaging and stability claims
  • method-of-use or dosing regimen claims

What to model once product identifiers are known

• Patent-by-patent expiration schedule:
  • Composition/formulation patents (premix stability, excipient system)
  • Process patents (preparation/manufacturing steps)
  • Method-of-use (if any) for rate control regimens
• FDA exclusivity categories:
  • 5-year new chemical entity or new formulation exclusivity (if applicable)
  • 3-year new clinical investigation (if applicable)
  • 7-year orphan/pediatric (rare for this use case unless specific subpopulation qualifies)
• Paragraph IV landscape:
  • identifying generic filers and likely settlement risk

FDA status: What is the Orange Book status of diltiazem hydrochloride in 0.72% sodium chloride?

Featured-snippet answer: Orange Book status cannot be stated without identifying the exact NDA/ANDA and NDC that correspond to “diltiazem hydrochloride in 0.72% sodium chloride.”

What “status” usually includes

• Listed patents with expiration dates
• Exclusivity expiration
• Marketed product labeling that can drive product substitution

Competitive landscape: Which companies sell diltiazem hydrochloride IV premix?

Featured-snippet answer: A company-level competitive map cannot be produced to the diluent-specific SKU without confirmed NDC-level product listings.

Typical competitor categories

• Branded injectable (if any)
• Authorized generics
• Multiple ANDA products differing by:
  • concentration
  • premix diluent
  • bag size and delivery system

What affects share in acute IV markets

• Contracting and stocking decisions
• Stability/compatibility with common infusion fluids
• Supply reliability and recall history

Formulation differentiation: What is special about 0.72% sodium chloride?

Featured-snippet answer: A precise formulation advantage for 0.72% sodium chloride cannot be claimed without a label/manufacturer dossier or stability/compatibility study tied to that exact diluent. Open sources usually treat diluent as preparation detail rather than a clinically pivotal variable.

Key formulation questions that drive acceptance

• Osmolality and compatibility with infusion sets
• Stability of diltiazem in solution over typical ICU/ED infusion durations
• Adsorption to bag materials and infusion tubing
• pH and chemical integrity across room-temperature handling periods

Litigation and settlement: What patent litigation affects diltiazem hydrochloride IV?

Featured-snippet answer: Litigation cannot be mapped to this exact formulation without Orange Book identification of the corresponding patents and NDC-linked cases. Diltiazem-related litigation exists at various product and method levels, but linking it to “0.72% sodium chloride” requires product-specific patent listings and case dockets.

Clinical adoption: How does diltiazem IV compare with alternatives for AFib/flutter with RVR?

Featured-snippet answer: For rate control in AFib/flutter with RVR, IV diltiazem competes with beta-blockers, amiodarone in selected cases, and sometimes digoxin in constrained populations. Outcome comparisons depend on patient hemodynamics and comorbidity, not the diluent alone.

Common comparative decision drivers

• Hemodynamic stability (diltiazem can worsen hypotension in vulnerable patients)
• Contraindications: conduction disease, severe HFrEF, bradycardia risk
• Time-to-rate control and rescue medication frequency

What generic entry risks exist for this exact product?

Featured-snippet answer: Generic entry risk cannot be assessed for “diltiazem hydrochloride in 0.72% sodium chloride” without:

• product-level FDA identifiers
• corresponding Orange Book patent set and exclusivity expiry
• any approved ANDA/ANDA tentative approvals or litigation outcomes

Key Takeaways

• A formulation- and diluent-specific clinical trials update, FDA status, patent/exclusivity timeline, and market forecast for “diltiazem hydrochloride in 0.72% sodium chloride” cannot be produced accurately without NDC/Orange Book linkage to the exact marketed product.
• Reliable market projections for IV diltiazem depend on separating SKUs by concentration, diluent, package configuration, and NDC-level availability.
• Investors and litigators should model exclusivity and Paragraph IV risk at the NDA/ANDA-NDC level, not from generic “diltiazem hydrochloride IV” evidence.

FAQs

1. What does the FDA label for IV diltiazem typically specify about preparation and diluent?
2. Are there clinical trials comparing IV diltiazem versus beta-blockers for AFib with RVR that specify the infusion diluent?
3. How do hospital formulary contracts typically price IV diltiazem bags versus compounded solutions?
4. What are the most common safety signals reported for IV diltiazem infusion in acute care settings?
5. How should analysts map Orange Book patents to a specific IV premix NDC for generic risk scoring?

References

1. (No sources cited because product-specific FDA/Orange Book, NDC, trial registries specifying “0.72% sodium chloride,” and patent-lifecycle data were not provided in the prompt.)