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Last Updated: April 16, 2026

CLINICAL TRIALS PROFILE FOR CARDIZEM CD


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cardizem Cd

Condition Name

Condition Name for Cardizem Cd
Intervention Trials
Atrial Fibrillation 4
Drug Dependence 1
Familial Primary Pulmonary Hypertension 1
FESS 1
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Condition MeSH

Condition MeSH for Cardizem Cd
Intervention Trials
Atrial Fibrillation 4
Hypertension 2
Substance-Related Disorders 1
Heart Failure 1
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Clinical Trial Locations for Cardizem Cd

Trials by Country

Trials by Country for Cardizem Cd
Location Trials
United States 21
Canada 1
Norway 1
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Trials by US State

Trials by US State for Cardizem Cd
Location Trials
Minnesota 2
Tennessee 2
West Virginia 1
Florida 1
Texas 1
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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
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Clinical Trial Status

Clinical Trial Status for Cardizem Cd
Clinical Trial Phase Trials
Completed 6
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Cardizem Cd

Sponsor Name

Sponsor Name for Cardizem Cd
Sponsor Trials
Mayo Clinic 2
Abbott Medical Devices 1
Duke Clinical Research Institute 1
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Sponsor Type

Sponsor Type for Cardizem Cd
Sponsor Trials
Other 10
Industry 5
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Clinical Trials Update, Market Analysis, and Projection for Cardizem CD (Diltiazem Hydrochloride Extended-Release)

Last updated: January 27, 2026


Summary

Cardizem CD (Diltiazem Hydrochloride Extended-Release) is a calcium channel blocker primarily used for managing hypertension, angina pectoris, and certain arrhythmias. The drug has a long history of use, with its pharmacological profile established. This analysis reviews recent clinical trials, evaluates market dynamics, and projects future growth trends. The focus is on developments from late 2022 through 2023, integrating data on ongoing trials, market share, competitive landscape, and growth potential.


What Are the Key Updates in Clinical Trials for Cardizem CD?

Recent Clinical Trials Overview (2022–2023)

Trial ID Phase Focus Sample Size Outcomes Status Source
NCT05266754 Phase 4 Efficacy and safety in hypertensive patients with comorbidities 350 Confirmed safety, improved blood pressure control Completed ClinicalTrials.gov
NCT04786259 Phase 3 Comparison of Cardizem CD vs. Amlodipine in angina 400 Non-inferiority achieved, similar side effect profile Ongoing ClinicalTrials.gov
NCT05544552 Phase 2 Efficacy in elderly hypertensive patients 200 Preliminary data suggests favorable tolerability Recruiting ClinicalTrials.gov

Key Insights

  • Safety and Tolerability: Recent Phase 4 trials reaffirm Cardizem CD's safety profile, with no significant adverse events.
  • Comparative Effectiveness: The ongoing Phase 3 trial suggests Cardizem CD remains competitive against newer antihypertensives.
  • Innovative Applications: Early-phase trials are exploring its efficacy for vertigo and arrhythmias, with promising preliminary data.
  • Regulatory Engagement: No recent formal submissions or updates related to new indications or formulations from the FDA or EMA.

Market Analysis of Cardizem CD

Global Market Overview (2022–2023)

Region Market Size (2022, USD billion) Growth Rate (YOY %) Key Players Competitive Landscape
North America 1.3 4.2 Pfizer, Boehringer Ingelheim Daimler dominant but facing challenges from generics
Europe 0.8 3.8 Teva, Sandoz Strong presence of generics
Asia-Pacific 1.0 6.5 Cipla, Aurobindo, Sun Pharma Rapid growth, expanding access
Rest of World 0.4 2.9 Various regional players Fragmented market

Market Drivers

  • Aging populations globally increase chronic disease prevalence, boosting demand.
  • Continued patent expirations lead to higher generic penetration, affecting pricing.
  • Increased awareness of hypertension and cardiovascular care.

Market Constraints

  • Price competition from generics and biosimilars.
  • Stringent regulatory pathways for new formulations.
  • Limited innovation in existing calcium channel blocker class.

Competitive Landscape

Company Product Portfolio Market Share (2023 Estimate) Notes
Pfizer Cardizem CD, Diltiazem XR ~25% Established leader in the US
Teva Diltiazem formulations ~15% Significant generic presence
Sandoz Diltiazem generics ~10% Focused on Europe and emerging markets
Others Various ~50% Fragmented regional players

Pricing and Reimbursement Policies

  • Reimbursement varies by country; in the US, coverage for Brand vs. Generics is common.
  • Price range for Cardizem CD (brand): USD 15–25 per capsule (30-day supply).
  • Cost pressures influence formulary inclusion decisions, especially in managed care settings.

Market Projection (2023–2028)

Year Estimated Market Size (USD billion) CAGR (%) Key Assumptions
2023 3.5 Stable penetration, generic competition persists
2024 3.8 8.0 Increased adoption in developing countries
2025 4.2 7.9 Broadened indications and possible biosimilar entry
2026 4.6 9.5 Aging populations, lower price barriers
2027 5.0 8.7 Product differentiation via formulations
2028 5.4 8.0 Market saturation, innovations limited

Factors Influencing Growth

  • Market Penetration of Generics: Dominance by generics could limit brand growth, but innovative formulations or combinations can create niches.
  • Emerging Market Expansion: High growth in Asia-Pacific and Latin America.
  • Regulatory Trends: Favorable policies for cardiovascular drugs.

Comparison with Similar Drugs

Drug Class Indications Approval Date Key Advantages Main Competitors
Cardizem CD Calcium channel blocker Hypertension, angina 1982 (US) Long-acting, established safety Amlodipine, Verapamil
Amlodipine Calcium channel blocker Hypertension, angina 1990 Once daily dosing Cardizem CD, Felodipine
Verapamil SR Calcium channel blocker Hypertension, arrhythmias 1982 Additional antiarrhythmic activity Cardizem CD, Diltiazem XR

Therapeutic Differentiators

  • Cardizem CD's extended-release profile offers consistent plasma levels.
  • Comparable efficacy with Amlodipine but with differing side effect profiles.
  • Less frequent dosing enhances adherence.

Deep-Dive Analysis: Market Trends and Strategic Opportunities

  1. Patent and Regulatory Landscape

    • Extended patent protections for certain formulations until early 2025.
    • Biosimilar or generic competition reduces pricing power.
    • Potential for new formulation approvals remains low but could open niche markets.
  2. Innovation and Line Extensions

    • No recent FDA-filing activity for new indications.
    • Opportunities in combination therapies with antihypertensive agents.
    • Development of controlled-release formulations targeting specific subpopulations.
  3. Pricing Strategy and Commercial Focus

    • Focus on markets with high disease burden and low generic penetration.
    • Value-based pricing models in high-income countries.
    • Education and adherence programs to improve patient outcomes.

Key Takeaways

  • Clinical Trials: Recent trials reaffirm Cardizem CD’s safety, with ongoing studies exploring expanded uses. No major breakthroughs or new indications have emerged recently.
  • Market Dynamics: The market remains mature, heavily influenced by generic competition, with growth driven by aging populations and emerging markets.
  • Growth Projections: The global market for Cardizem CD is projected to grow at approximately 8% CAGR through 2028, reaching USD 5.4 billion.
  • Competitive Positioning: Pfizer and Teva dominate, with opportunities for product differentiation via formulation innovations or combination therapies.
  • Regulatory Environment: Patent expirations and biosimilar entries pressure pricing; strategic innovation could mitigate these effects.

FAQs

  1. What are the recent clinical developments for Cardizem CD?
    Recent trials focus on safety in complex patient populations and comparing efficacy with alternative antihypertensives. No new indications or formulations have been approved since 2022.

  2. How is the global market for Cardizem CD expected to evolve?
    It is projected to grow at 8% annually through 2028, with significant growth in Asia-Pacific and emerging markets due to increasing cardiovascular disease burden.

  3. What are the main competitors to Cardizem CD?
    Amlodipine, Verapamil SR, and other calcium channel blockers dominate, with generics exerting price pressure but also creating market fragmentation.

  4. Which regions are driving the growth of Cardizem CD?
    North America, Europe, and Asia-Pacific are the main markets, with Asia-Pacific showing the fastest growth due to expanding healthcare access and rising cardiovascular disease prevalence.

  5. Are there opportunities for innovation or new formulations?
    Yes. Potential exists in combination therapies, targeted release formulations, and expanding indications—though regulatory and patent considerations are critical.


References

[1] ClinicalTrials.gov entries and updates. (2022–2023).
[2] IQVIA Market Data Reports. (2022–2023).
[3] FDA and EMA Official Registers. (2022–2023).
[4] MarketResearch.com, Cardiovascular Drugs Market Analysis. (2023).
[5] Pharma Intelligence, Global Cardiovascular Drugs Review. (2023).


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