CLINICAL TRIALS PROFILE FOR CARDIZEM SR

All Clinical Trials for Cardizem Sr

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.
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	Duke Clinical Research Institute	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.
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	St. Jude Medical	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 Sr

Condition Name

Condition Name for Cardizem Sr
Intervention	Trials
Atrial Fibrillation	4
Familial Primary Pulmonary Hypertension	1
FESS	1
Healthy	1

Condition MeSH

Condition MeSH for Cardizem Sr
Intervention	Trials
Atrial Fibrillation	4
Hypertension	2
Familial Primary Pulmonary Hypertension	1
Substance-Related Disorders	1

Clinical Trial Locations for Cardizem Sr

Trials by Country

Trials by Country for Cardizem Sr
Location	Trials
United States	21
Canada	1
Norway	1

Trials by US State

Trials by US State for Cardizem Sr
Location	Trials
Minnesota	2
Tennessee	2
West Virginia	1
Florida	1
Texas	1

Clinical Trial Progress for Cardizem Sr

Clinical Trial Phase

Clinical Trial Phase for Cardizem Sr
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 1	3

Clinical Trial Status

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

Clinical Trial Sponsors for Cardizem Sr

Sponsor Name

Sponsor Name for Cardizem Sr
Sponsor	Trials
Mayo Clinic	2
Assiut University	1
Abbott Medical Devices	1

Sponsor Type

Sponsor Type for Cardizem Sr
Sponsor	Trials
Other	10
Industry	5

Cardizem SR: Clinical Trials, Market Analysis, and Projections

Introduction

Cardizem SR, a formulation of diltiazem hydrochloride, is a calcium channel blocker widely used in the treatment of hypertension, angina, and certain types of arrhythmias. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Mechanism of Action

Diltiazem works by relaxing blood vessels and reducing heart rate, thereby decreasing myocardial oxygen demand. It is effective in dilating coronary arteries, reducing systemic blood pressure, and increasing exercise tolerance in patients with angina[4].

Recent Clinical Studies

Clinical trials have consistently shown that diltiazem is effective in managing cardiovascular conditions. For instance, studies have demonstrated that diltiazem increases time to termination of exercise and decreases overall angina frequency in patients with stable angina. When combined with long-acting nitrates and/or beta-blockers, diltiazem has shown significant benefits without an increase in adverse events[1].

Ongoing and Future Trials

The global cardiovascular clinical trials market, which includes trials for drugs like Cardizem SR, is segmented into phases I to IV. Phase IV trials, which focus on post-marketing surveillance, dominate the market and are crucial for ensuring the ongoing safety and efficacy of cardiovascular medications like diltiazem[3].

Market Analysis

Market Size and Growth

The diltiazem market is projected to grow significantly, driven by increasing incidence of cardiovascular diseases and an aging population. By 2028, the market is expected to reach $832.51 million from $369.95 million in 2021, growing at a CAGR of 12.3%[2].

Product Type Insights

The market is segmented into capsules, injections, and tablets. While tablets currently hold the largest share, the capsules segment, which includes Cardizem SR, is expected to witness the fastest CAGR of 12.8% during the forecast period from 2021 to 2028[2].

Key Drivers

• Increasing Incidence of Cardiovascular Diseases: The rising prevalence of heart diseases, particularly among the elderly, is a significant driver. Cardiovascular diseases are the leading cause of death globally, and their incidence is increasing due to factors like sedentary lifestyles, unhealthy diets, and aging populations[5].
• Aging Population: The elderly population is more prone to cardiovascular diseases due to structural and functional changes in the cardiovascular system associated with aging. This demographic shift is expected to bolster the growth of the diltiazem market[2].

Market Challenges

Despite the growth potential, the market faces challenges such as side effects associated with diltiazem. These include potential prolongation of the PR interval, AV block, and various other adverse events like gingival hyperplasia, hemolytic anemia, and photosensitivity[4].

Market Projections

Global Outlook

The global cardiovascular disease drugs market, which includes diltiazem, is projected to grow from $55.32 billion in 2022 to $78.79 billion by 2030, registering a CAGR of 4.52% during the forecast period. This growth is driven by increasing awareness, early detection, and the need for precision medicine in managing cardiovascular diseases[5].

Regional Insights

North America currently dominates the market for cardiovascular clinical trials, including those for diltiazem, due to advanced infrastructure and innovative technologies. However, the Asia-Pacific region is expected to grow rapidly, driven by favorable regulatory reforms and increasing investment in clinical research in countries like China and India[3].

Key Players

The diltiazem market includes major players such as Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, Pfizer Inc, Glenmark, Sandoz (Novartis AG), Sun Pharmaceutical Company Ltd, Hikma Pharmaceuticals, and Zydus Pharmaceuticals. These companies are actively involved in research, development, and marketing of diltiazem formulations[2].

Key Takeaways

• Clinical Efficacy: Diltiazem has been proven effective in managing hypertension, angina, and certain arrhythmias through its mechanism of action.
• Market Growth: The diltiazem market is expected to grow significantly, driven by increasing cardiovascular disease incidence and an aging population.
• Product Segmentation: The capsules segment, including Cardizem SR, is expected to witness the fastest CAGR during the forecast period.
• Challenges: Side effects and adverse events associated with diltiazem are potential challenges to market growth.
• Global Outlook: The global cardiovascular disease drugs market is projected to grow substantially, with North America and Asia-Pacific being key regions.

FAQs

What is the primary mechanism of action of Cardizem SR?

Cardizem SR works by relaxing blood vessels and reducing heart rate, thereby decreasing myocardial oxygen demand and improving blood flow.

What are the key drivers of the diltiazem market?

The key drivers include the increasing incidence of cardiovascular diseases and an aging population, which lead to higher demand for cardiovascular medications.

Which segment of the diltiazem market is expected to grow the fastest?

The capsules segment, which includes Cardizem SR, is expected to witness the fastest CAGR during the forecast period from 2021 to 2028.

What are the potential side effects of diltiazem?

Potential side effects include prolongation of the PR interval, AV block, gingival hyperplasia, hemolytic anemia, and photosensitivity.

Who are the major players in the diltiazem market?

Major players include Bausch Health, Teva Pharmaceutical Industries Ltd, Mylan N.V, Athenex, Pfizer Inc, Glenmark, Sandoz (Novartis AG), Sun Pharmaceutical Company Ltd, Hikma Pharmaceuticals, and Zydus Pharmaceuticals.

Sources

1. Cardizem CD (diltiazem hydrochloride) capsule label - FDA
2. Diltiazem Market Size, Share & Growth Analysis by 2028 - The Insight Partners
3. Global Cardiovascular Clinical Trials Market Size To Exceed USD 9.76 Billion By 2033 - GlobeNewswire
4. Cardizem (diltiazem hydrochloride) tablets - FDA
5. Global Cardiovascular Disease Drugs Market Analysis - Insights10