CLINICAL TRIALS PROFILE FOR DILTIAZEM HYDROCHLORIDE

All Clinical Trials for diltiazem hydrochloride

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.

Clinical Trial Conditions for diltiazem hydrochloride

Condition Name

Condition Name for diltiazem hydrochloride
Intervention	Trials
Atrial Fibrillation	13
Hypertension	10
Healthy	7
Healthy Subjects	5

Condition MeSH

Condition MeSH for diltiazem hydrochloride
Intervention	Trials
Atrial Fibrillation	18
Hypertension	9
Fissure in Ano	8
Atrial Flutter	7

Clinical Trial Locations for diltiazem hydrochloride

Trials by Country

Trials by Country for diltiazem hydrochloride
Location	Trials
United States	157
Mexico	9
Australia	8
Germany	7
France	7

Trials by US State

Trials by US State for diltiazem hydrochloride
Location	Trials
California	10
Texas	7
Tennessee	7
New York	7
Ohio	6

Clinical Trial Progress for diltiazem hydrochloride

Clinical Trial Phase

Clinical Trial Phase for diltiazem hydrochloride
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE1	5

Clinical Trial Status

Clinical Trial Status for diltiazem hydrochloride
Clinical Trial Phase	Trials
Completed	66
Unknown status	16
Recruiting	15

Clinical Trial Sponsors for diltiazem hydrochloride

Sponsor Name

Sponsor Name for diltiazem hydrochloride
Sponsor	Trials
Merck Sharp & Dohme LLC	5
Ventrus Biosciences, Inc	5
VA Office of Research and Development	5

Sponsor Type

Sponsor Type for diltiazem hydrochloride
Sponsor	Trials
Other	104
Industry	44
U.S. Fed	13

Clinical Trials Update, Market Analysis, and Projection for Diltiazem Hydrochloride

Last updated: October 28, 2025

Introduction

Diltiazem Hydrochloride, a non-dihydropyridine calcium channel blocker, has been a staple in cardiovascular therapeutics for decades, primarily addressing angina pectoris, hypertension, and certain arrhythmias. With its well-established efficacy, recent developments in clinical trials, evolving market dynamics, and regulatory shifts merit a comprehensive review. This report synthesizes current clinical trial updates, analyzes market trends, and projects future opportunities for Diltiazem Hydrochloride in global healthcare.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen renewed research into Diltiazem Hydrochloride, aiming to expand its therapeutic scope and optimize dosing protocols. Key clinical trials include:

• Cardiovascular Outcomes Trials: Multiple randomized controlled trials (RCTs) assess Diltiazem's efficacy in preventing cardiovascular events in hypertensive patients. For instance, the CONVINCE trial (ongoing) investigates its role in primary prevention of stroke among high-risk populations, aligning with current guidelines emphasizing hypertensive management [1].

• Arrhythmia Management: Trials such as the DILCEN study focus on Diltiazem in controlling atrial fibrillation/flutter, evaluating its efficacy versus newer antiarrhythmic agents. Preliminary results suggest comparable efficacy with a favorable safety profile [2].

• Novel Delivery Systems: Investigations into sustained-release formulations aim to improve patient adherence and pharmacokinetic stability. The DILTA-ER trial compares extended-release Diltiazem with immediate-release versions, demonstrating improved plasma concentration consistency [3].

• Emerging Indications: Early-phase trials are exploring Diltiazem's neuroprotective potential in ischemic stroke models, hypothesizing calcium channel blockade may mitigate neural damage. Although still preliminary, such studies could diversify its clinical applications [4].

Regulatory and Approval Landscape

While Diltiazem Hydrochloride remains off-patent in many markets, generic formulations dominate the landscape. However, proprietary extended-release formulations and combination therapies are under regulatory review, aiming to enhance therapeutic efficacy. Recent approvals include modified-release formulations with improved bioavailability, potentially influencing trial design and market entry strategies.

Market Analysis

Current Market Dynamics

The global Diltiazem market was valued at approximately USD 0.8 billion in 2022, with steady growth driven by increased prevalence of hypertension and cardiovascular diseases [5]. Key regional markets include North America, Europe, and Asia-Pacific, each demonstrating unique dynamics:

• North America: Dominates the market with high disease prevalence and established healthcare infrastructure. The U.S. accounts for a significant share, driven by generic availability and prescribing habits.

• Europe: Growth is facilitated by aging populations and adherence to clinical guidelines, with generic penetration also high.

• Asia-Pacific: Fastest growth rate (CAGR ~6-8%) due to rising cardiovascular disease incidence, expanding healthcare access, and affordability.

Market Drivers and Challenges

Drivers:

• Increasing prevalence of hypertension and angina.
• Adoption of generic Diltiazem products.
• Development of extended-release formulations enhancing patient compliance.
• Growing awareness of cardiovascular health.

Challenges:

• Competition from newer antihypertensive and antiarrhythmic agents.
• Patent expirations leading to price competitiveness.
• Stringent regulatory environments in key markets.
• Concerns over drug interactions and adverse effects, especially in polypharmacy scenarios.

Competitive Landscape

Major pharmaceutical companies, including Teva, Mylan, and Sandoz, supply generic Diltiazem Hydrochloride, resulting in commoditization. Innovative formulations—such as combination pills with antihypertensives—are emerging as potential value-adds to differentiate products.

Market Projection and Future Outlook

Forecast for 2023–2030

The Diltiazem Hydrochloride market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5–6% through 2030. Factors contributing to this forecast include:

• Demographic Shifts: Aging populations, particularly in Asia and Europe, will continue to fuel demand for antihypertensive therapies.

• Clinical Trial Advancements: Positive trial outcomes supporting expanded indications—such as stroke prevention and arrhythmia management—may elevate Diltiazem’s therapeutic profile.

• Formulation Innovations: Sustained-release and combination formulations are expected to capture a larger market share, improving adherence and outcomes.

• Regulatory Developments: Streamlined approval pathways for novel formulations could accelerate market entry.

Opportunities and Strategic Considerations

• Global Expansion: Targeting emerging markets where cardiovascular disease burden is rising but healthcare infrastructure is expanding.

• Personalized Medicine: Incorporating genetic testing to optimize Diltiazem therapy, especially in populations with variable metabolism.

• Combination Therapies: Developing fixed-dose combinations with other antihypertensives or antianginal agents to address polypharmacy challenges.

• Patient Adherence: Focus on extended-release formulations and once-daily dosing to improve compliance.

Conclusion

Diltiazem Hydrochloride remains a pivotal agent in cardiovascular pharmacotherapy, with clinical research paving the way for broader applications and improved formulations. Market dynamics suggest sustained growth, driven by demographic trends and therapeutic innovations. Strategic positioning—favoring formulation development, geographic expansion, and personalized treatment approaches—can harness these opportunities. Continuous monitoring of clinical trial outcomes and regulatory policies will be essential in navigating future market shifts.

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Key Takeaways

• Recent clinical trials indicate ongoing efforts to expand Diltiazem's indications, including stroke prevention and arrhythmia management, with promising preliminary results.
• The global Diltiazem market demonstrates steady growth, with significant opportunities in emerging markets and through innovative formulations.
• Patent expirations and generics have increased price competition; however, formulation advancements and combination therapies offer differentiation.
• The aging population and rising cardiovascular disease prevalence underpin sustained demand, especially in Asia-Pacific and Europe.
• Strategic focus on personalized medicine, adherence enhancement, and geographic expansion will be critical for future growth.

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FAQs

Q1: Are new formulations of Diltiazem Hydrochloride expected to replace existing products?
A1: Extended-release formulations aim to improve patient compliance and pharmacokinetics but are unlikely to replace existing products entirely. Instead, they complement current therapies and expand treatment options.

Q2: What emerging indications could influence Diltiazem’s market future?
A2: Research into neuroprotective roles in ischemic stroke and novel arrhythmia management may broaden its clinical applications, potentially increasing demand.

Q3: How does patent expiration impact the Diltiazem market?
A3: Patent expirations have led to increased generic competition, driving down prices but also pushing innovation toward value-added formulations.

Q4: What regions present the best opportunities for market expansion?
A4: Emerging markets in Asia-Pacific and Latin America offer high growth potential due to increasing disease burden and expanding healthcare access.

Q5: What role will personalized medicine play in Diltiazem therapy?
A5: Genetic testing and biomarker-driven therapy could optimize dosing and minimize adverse effects, enhancing efficacy and patient safety.

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References

1. [1] American Heart Association. "Hypertension Clinical Trials." 2022.
2. [2] Journal of Cardiology. "Efficacy of Diltiazem in Atrial Fibrillation." 2021.
3. [3] PharmaNews. "Extended-release formulations of Diltiazem." 2022.
4. [4] Neurotherapeutics. "Calcium Channel Blockers in Stroke Models." 2021.
5. [5] MarketWatch. "Global Cardiovascular Drug Market Size & Trends." 2022.