CLINICAL TRIALS PROFILE FOR CARDIZEM LA

All Clinical Trials for cardizem la

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.

Clinical Trial Conditions for cardizem la

Condition Name

Condition Name for cardizem la
Intervention	Trials
Atrial Fibrillation	4
Pulmonary Arterial Hypertension	1
Diltiazim	1

Condition MeSH

Condition MeSH for cardizem la
Intervention	Trials
Atrial Fibrillation	4
Hypertension	2
Heart Failure	1

Clinical Trial Locations for cardizem la

Trials by Country

Trials by Country for cardizem la
Location	Trials
United States	21
Norway	1
Canada	1

Trials by US State

Trials by US State for cardizem la
Location	Trials
Minnesota	2
Tennessee	2
Florida	1
Texas	1
Kansas	1

Clinical Trial Progress for cardizem la

Clinical Trial Phase

Clinical Trial Phase for cardizem la
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status for cardizem la
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for cardizem la

Sponsor Name

Sponsor Name for cardizem la
Sponsor	Trials
Mayo Clinic	2
St. Jude Medical	1
Medtronic	1

Sponsor Type

Sponsor Type for cardizem la
Sponsor	Trials
Other	10
Industry	5

Clinical Trials Update, Market Analysis, and Projection for Cardizem LA

Last updated: October 28, 2025

Introduction

Cardizem LA (Diltiazem Hydrochloride Extended-Release Capsules) is a calcium channel blocker primarily used for the management of hypertension, angina pectoris, and certain arrhythmias. With a significant market share in the cardiovascular drug segment, ongoing clinical developments, regulatory updates, and competitive dynamics substantially influence its market position. This report provides a comprehensive overview of recent clinical trial activities, market trends, and future projections for Cardizem LA, enabling industry stakeholders to make informed strategic decisions.

Clinical Trials Update

Recent and Ongoing Clinical Trials

While Cardizem LA has a long-standing approval status, recent clinical research focuses on its expanded indications, comparative efficacy, safety profiles, and formulation optimization.

• New Therapeutic Applications: Emerging trials investigate Cardizem LA for off-label uses, including specific arrhythmic disorders and resistant hypertension, with some studies exploring its role in heart failure management. These trial phases aim to establish safety and efficacy in diverse patient populations.

• Formulation and Bioavailability Studies: Attempts to enhance its pharmacokinetics involve evaluating novel extended-release formulations focusing on dose flexibility and reduced side effects. Notably, some pilot studies test combination therapies integrating Cardizem LA with other antihypertensives or anti-arrhythmics.

• Comparative Effectiveness Research: Several head-to-head clinical trials compare Cardizem LA with other calcium channel blockers like amlodipine or sustained-release formulations to determine superiority in blood pressure control, adverse event profiles, and patient compliance.

Regulatory and Safety Updates

• FDA and EMA Clearance: Cardizem LA has maintained its regulatory status, with recent updates indicating ongoing post-marketing surveillance studies to monitor long-term safety, particularly in elderly populations and those with concomitant polypharmacy.

• Clinical Trial Outcomes: Latest results confirm its efficacy in managing stable angina and hypertension, with adverse events largely limited to mild dizziness and peripheral edema. These findings bolster its safety profile, supporting continued widespread use.

Research Gaps and Future Directions

• Personalized Medicine Focus: Future trials aim at identifying genetic markers influencing individual responses to Cardizem LA, aligning with personalized treatment strategies.

• Combination Therapy Trials: Investigations into synergistic effects with other cardiovascular drugs, especially in resistant cases, are gaining momentum, promising potential market expansion.

Market Analysis

Market Size and Growth Dynamics

The global calcium channel blocker market, estimated at approximately USD 6.7 billion in 2022, continues to grow at a compound annual growth rate (CAGR) of around 4.2%. Cardizem LA specifically contributes significantly within this segment due to its established efficacy and favorable safety profile.

• Regional Market Shares: North America dominates, accounting for circa 45% of sales, driven by high hypertension prevalence and robust healthcare infrastructure. Europe follows, with emerging markets in Asia-Pacific showing rapid growth due to rising cardiovascular disease incidence.

• Market Drivers: The increasing prevalence of hypertension and angina worldwide, aging populations, and favorable insurance reimbursement policies underpin sustained demand.

Competitive Landscape

• Key Competitors: Other leading calcium channel blockers, such as amlodipine, nifedipine, and verapamil, challenge Cardizem LA's market share. Modern formulations offering once-daily dosing and improved side effect profiles are reshaping competition.

• Generic Entry and Pricing Strategies: The expiration of patents and regulatory pathways facilitating generic versions have intensified price competition, pressuring brand-name formulations like Cardizem LA.

• Innovative Therapies: Non-calcineurin calcium channel blockers with targeted delivery methods (e.g., transdermal, injectable) are emerging threats, necessitating continuous innovation for Cardizem LA.

Market Challenges

• Side Effect Management: Peripheral edema and dizziness remain common adverse effects, impacting patient adherence and limiting use in certain populations.

• Regulatory Hurdles and Reimbursement Policies: Stringent approval processes and variable reimbursement landscapes influence market expansion strategies.

• Patent and Intellectual Property Risks: While the original formulation's patent has expired, newer formulations and combination products are protected, creating opportunities for lifecycle management.

Market Projection

Short-term Outlook (Next 3 Years)

The Cardizem LA market is expected to maintain steady growth, supported by increasing global hypertension and angina prevalence, and incremental clinical validation. The expansion into emerging markets and ongoing clinical trials for new indications are anticipated to augment sales.

Long-term Outlook (Next 5-10 Years)

• Market Growth: Projected CAGR of approximately 3.5%-4% globally, reaching an estimated USD 8-9 billion by 2030.

• Market Share Dynamics: While generic competition may erode some revenues, continued innovation, such as extended-release formulations and combination therapies, will sustain its competitive edge.

• Regulatory and Healthcare Trends: Growing adoption of personalized medicine and telehealth integration will influence prescribing patterns, potentially favoring more targeted formulations.

Strategic Recommendations

• Research & Development: Focus on developing next-generation formulations with improved side-effect profiles and bioavailability.

• Geographic Expansion: Increase efforts in emerging markets where cardiovascular disease burden is rising.

• Partnerships: Collaborate with biotech firms to explore innovative drug delivery systems.

Key Takeaways

• Clinical reiteration confirms Cardizem LA’s efficacy and safety, reinforcing its vital role in cardiovascular therapy; however, ongoing clinical studies are exploring expanded uses and combination therapies.

• Market competitiveness is intensifying, driven by patent expirations, generic entries, and emerging therapeutic alternatives, emphasizing the need for strategic differentiation.

• Growth projections remain robust in both established and emerging markets, with a strategic focus on formulation innovation, geographic expansion, and personalized medicine positioning key to future success.

• Regulatory and reimbursement landscapes will critically influence market trajectories, necessitating proactive compliance and pricing strategies.

• Innovation, diversification, and market agility are vital for stakeholders to capitalize on the evolving landscape surrounding Cardizem LA.

FAQs

Q1: What are the primary clinical indications for Cardizem LA?
A1: Cardizem LA is primarily indicated for hypertension, chronic stable angina, and certain types of arrhythmias, including atrial fibrillation/flutter with rapid ventricular response.

Q2: How does Cardizem LA compare to other calcium channel blockers?
A2: Cardizem LA offers sustained blood pressure control with once-daily dosing and a favorable side effect profile. Comparative studies indicate similar efficacy to other agents like amlodipine, with some differences in tolerability profiles.

Q3: Are there ongoing studies exploring new uses for Cardizem LA?
A3: Yes, recent clinical trials are investigating its off-label potential in resistant hypertension, certain arrhythmic conditions, and as part of combination therapies for complex cardiovascular cases.

Q4: What impact will generic competition have on Cardizem LA’s market share?
A4: Patent expirations have led to increased generic options, which exert downward pricing pressure and threaten premium pricing of branded formulations. Innovating formulations and expanding indications are key countermeasures.

Q5: What future market trends could influence Cardizem LA’s growth prospects?
A5: Trends include growth in emerging markets, advancements in drug delivery systems, personalized medicine integration, and shifting healthcare policies focusing on chronic disease management.

---

References

[1] Market Research Future. “Global Calcium Channel Blockers Market Analysis,” 2022.
[2] FDA Drug Approvals and Safety Data. “Cardizem (Diltiazem) Clinical Summary,” 2023.
[3] IQVIA. “Global Cardiovascular Drugs Market Report,” 2022.
[4] ClinicalTrials.gov. “Sponsored Trials on Diltiazem and Cardizem,” 2023.
[5] World Health Organization. “Cardiovascular Disease Burden and Management,” 2022.