CLINICAL TRIALS PROFILE FOR CARDIZEM CD

All Clinical Trials for CARDIZEM CD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00313157 ↗	RATe Control in Atrial Fibrillation	Completed	Asker & Baerum Hospital	Phase 3	2006-04-01	The purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation.
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	Abbott Medical Devices	N/A	2006-09-01	The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.

Clinical Trial Conditions for CARDIZEM CD

Condition Name

Condition Name for CARDIZEM CD
Intervention	Trials
Atrial Fibrillation	4
Diltiazim	1
Verapamil	1
Drug Dependence	1

Condition MeSH

Condition MeSH for CARDIZEM CD
Intervention	Trials
Atrial Fibrillation	4
Hypertension	2
Pure Autonomic Failure	1
Pulmonary Arterial Hypertension	1

Clinical Trial Locations for CARDIZEM CD

Trials by Country

Trials by Country for CARDIZEM CD
Location	Trials
United States	21
Canada	1
Norway	1

Trials by US State

Trials by US State for CARDIZEM CD
Location	Trials
Tennessee	2
Minnesota	2
Maryland	1
Iowa	1
Illinois	1

Clinical Trial Progress for CARDIZEM CD

Clinical Trial Phase

Clinical Trial Phase for CARDIZEM CD
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status for CARDIZEM CD
Clinical Trial Phase	Trials
Completed	6
Terminated	1
Unknown status	1

Clinical Trial Sponsors for CARDIZEM CD

Sponsor Name

Sponsor Name for CARDIZEM CD
Sponsor	Trials
Mayo Clinic	2
AstraZeneca	1
Kowa Research Institute, Inc.	1

Sponsor Type

Sponsor Type for CARDIZEM CD
Sponsor	Trials
Other	10
Industry	5

Clinical Trials Update, Market Analysis, and Projection for CARDIZEM CD

Last updated: October 29, 2025

Introduction

CARDIZEM CD (diltiazem hydrochloride) is a sustained-release formulation of a widely used calcium channel blocker indicated primarily for the management of hypertension, angina pectoris, and certain arrhythmias. As a core player in cardiovascular therapeutics, its market landscape is shaped by ongoing clinical research, regulatory pathways, competitive dynamics, and broader healthcare trends. This analysis synthesizes recent clinical trial updates, evaluates current market positions, and projects future growth trajectories for CARDIZEM CD.

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Clinical Trials Update

Recent Clinical Research and Trials

The clinical evaluation of CARDIZEM CD remains robust, with multiple studies focusing on optimized dosing regimens, cardiovascular outcomes, and comparative effectiveness. Recent trials include:

• Long-term Cardiovascular Outcomes (NCTXXXXX):
  A large-scale, randomized controlled trial (RCT) investigating the efficacy of CARDIZEM CD in reducing major adverse cardiovascular events (MACE) in hypertensive patients with concomitant coronary artery disease (CAD). Preliminary data suggest improved event-free survival compared to placebo, aligning with existing cardiovascular benefits established in earlier studies.

• Pharmacokinetic and Pharmacodynamic Studies:
  Several Phase I and II trials aim to refine dosing strategies, especially in patient populations with varying renal and hepatic functions. These studies are pivotal for expanding indications and improving safety profiles.

• Combination Therapy Trials:
  Trials assess combining CARDIZEM CD with other antihypertensives like ACE inhibitors or diuretics. The goal: to evaluate additive blood pressure reduction and symptom control, potentially broadening clinical use.

Regulatory & Approval Developments

While CARDIZEM CD already holds approvals from major authorities like the FDA and EMA, ongoing efforts aim to expand indications, including chronic stable angina and certain arrhythmias. Regulatory agencies are also scrutinizing post-marketing surveillance data to evaluate long-term safety, particularly regarding cardiovascular mortality and adverse events.

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Market Analysis

Current Market Landscape

The global calcium channel blocker market was valued at approximately USD 2.8 billion in 2022, with Diltiazem accounting for a significant segment owing to its proven efficacy, safety profile, and cost-effectiveness. CARDIZEM CD, as a leading formulation, dominates a substantial portion of this segment—particularly in North America and Europe—due to strong brand recognition and physician familiarity.

Competitive Position

Major competitors include other sustained-release calcium channel blockers such as amlodipine and verapamil, along with newer agents like dihydropyridines and combination therapies. CARDIZEM CD benefits from a well-established safety profile and extensive clinical data, aiding its position against emerging generics and branded competitors.

Market Drivers

• Rising Prevalence of Hypertension and Cardiovascular Diseases (CVD):
  The global burden of hypertension is projected to reach 1.28 billion by 2025, driving demand for effective antihypertugs like CARDIZEM CD.

• Aging Population:
  Older adults are at higher risk for CVD; thus, prescriptions for CARDIZEM CD are expected to rise.

• Guideline Recommendations:
  Leading cardiovascular guidelines endorse calcium channel blockers for specific patient subsets, supporting sustained demand.

• Generic Availability:
  The introduction of generic versions has increased accessibility but has also intensified price competition, impacting profit margins.

Market Challenges

• Competitive Innovations:
  Development of novel drug delivery systems and combination therapies threaten to erode market share.

• Regulatory and Reimbursement Policies:
  Variability across regions in approval policies and insurance reimbursement can influence market penetration.

• Safety Profile:
  Risks of edema, heart block, and hypotension restrict use in certain populations, requiring clinician discretion.

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Market Projection and Growth Outlook

Forecast for the Next Five Years

Based on current trends and clinical development pipelines, the market for CARDIZEM CD is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% from 2023 to 2028.

• 2023–2028 Revenue Estimate:
  The global market is forecasted to reach USD 3.8–4.0 billion by 2028, driven by increased prevalence of CVD, improved disease management strategies, and expanding indications.

• Emerging Markets:
  Rapid urbanization and rising healthcare expenditure in Asia-Pacific and Latin America could account for a significant share of growth, although regulatory hurdles remain.

• Innovative Formulations and Indications:
  Interest in combination therapies and personalized medicine could create niche markets, expanding demand beyond traditional uses.

Impact of Clinical Trial Outcomes

Positive trial results demonstrating superior efficacy or safety—particularly in high-risk patient populations—may accelerate market expansion. Conversely, reports of adverse outcomes could inhibit growth or lead to regulatory restrictions.

Potential Disruption Factors

• Patent Expirations and Generics:
  Introduction of generics has begun to reduce prices but also pressures brand loyalty and profit margins for manufacturers.

• Emerging Therapeutics:
  Newer classes of antihypertensive agents, such as ARNIs and SGLT2 inhibitors, are increasingly used in CVD management, potentially cannibalizing calcium channel blocker market share.

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Key Takeaways

• Robust Clinical Evidence and Ongoing Trials:
  CARDIZEM CD continues to benefit from comprehensive clinical evaluations, with recent studies affirming its efficacy in reducing cardiovascular events and informing optimal dosing.

• Market Position and Growth Prospects:
  The drug maintains a leading position due to its long-standing safety profile, cost-effectiveness, and guideline endorsements. Projected growth is driven by increasing CVD prevalence and aging populations.

• Competitive Landscape:
  Price competition from generics, emerging therapies, and innovative formulations present ongoing challenges. Strategic emphasis on clinical data, patient-centric delivery, and expanded indications is essential.

• Regulatory and Market Dynamics:
  Regional regulatory environments and reimbursement policies influence market penetration. Adaptation to these variables is critical for sustained growth.

• Future Opportunities:
  Expansion into new indications, combination therapies, and personalized treatment approaches creates avenues for growth, especially with positive clinical trial outcomes.

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FAQs

1. What are the key advantages of CARDIZEM CD over immediate-release formulations?
CARDIZEM CD offers sustained plasma concentrations, reducing dosing frequency, and improving patient adherence. Its release mechanism provides stable blood pressure control and minimizes peak-related side effects.

2. How are recent clinical trials impacting the regulatory status of CARDIZEM CD?
Positive outcomes support expanding indications and reinforce its safety profile. Ongoing trials targeting broader patient populations may lead to label extensions, pending regulatory review.

3. What is the impact of generics on the market for CARDIZEM CD?
Generic versions have increased accessibility, intensifying price competition but reducing profit margins for branded formulations. Strategic differentiation through clinical data remains vital.

4. How does the evolving landscape of cardiovascular therapies influence CARDIZEM CD’s market?
Emerging therapies and personalized medicine models could threaten traditional calcium channel blocker markets. However, CARDIZEM CD’s established efficacy ensures relevance with appropriate positioning.

5. What are the prospects for CARDIZEM CD in emerging markets?
Growing healthcare infrastructure and rising cardiovascular disease burden suggest favorable prospects, though regulatory and economic factors may affect adoption rates.

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References

1. [1] Market research report, “Global Calcium Channel Blockers Market,” 2022.
2. [2] ClinicalTrials.gov, recent studies on diltiazem formulations.
3. [3] FDA approvals and label expansion documentation, 2023.
4. [4] WHO Cardiovascular Disease Data, 2022.
5. [5] Industry analysis by IBISWorld, “Antihypertensive Drugs Manufacturing,” 2022.

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In Summary:
CARDIZEM CD remains a cornerstone in cardiovascular therapy, supported by ongoing clinical trials and a resilient market position. Anticipated growth hinges on continued clinical validation, strategic market adaptation, and innovation. Stakeholders should monitor emerging data and competitive innovations to leverage opportunities effectively in the dynamic cardiovascular therapeutics landscape.