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.
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 la

Condition Name

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

Condition MeSH

Condition MeSH for cardizem la
Intervention	Trials
Atrial Fibrillation	4
Hypertension	2
Substance-Related Disorders	1
Heart Failure	1

Clinical Trial Locations for cardizem la

Trials by Country

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

Trials by US State

Trials by US State for cardizem la
Location	Trials
Minnesota	2
Tennessee	2
West Virginia	1
Florida	1
Texas	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
Withdrawn	1
Not yet recruiting	1

Clinical Trial Sponsors for cardizem la

Sponsor Name

Sponsor Name for cardizem la
Sponsor	Trials
Mayo Clinic	2
Abbott Medical Devices	1
Duke Clinical Research Institute	1

Sponsor Type

Sponsor Type for cardizem la
Sponsor	Trials
Other	10
Industry	5

Cardizem la Market Analysis and Financial Projection

CARDIZEM LA: Clinical Trials, Market Analysis, and Projections

Introduction

CARDIZEM LA, a formulation of the calcium channel blocker diltiazem, is widely used for the management of chronic stable angina and hypertension. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials for CARDIZEM LA

Angina Trials

In a randomized, double-blind, parallel-group, dose-response trial, the efficacy of CARDIZEM LA was evaluated in 311 patients with chronic stable angina. Patients received evening doses of either placebo or CARDIZEM LA at 180 mg, 360 mg, and 420 mg, or a morning dose of 360 mg. The results showed that all doses of CARDIZEM LA administered at night increased exercise tolerance compared to placebo after 21 hours, with a mean effect of 20 to 28 seconds. The morning dose of 360 mg also improved exercise tolerance when measured 25 hours later, although the effect was smaller than that observed after nighttime administration[1][4].

Hypertension Trials

The efficacy of CARDIZEM LA in treating hypertension was evaluated in two randomized, double-blind, parallel-group, dose-response studies. The first study involved 478 patients with essential hypertension, who received doses ranging from 120 mg to 540 mg once daily in the morning. The results indicated significant reductions in diastolic blood pressure, with mean reductions of –2.0, –4.4, –6.4, and –8.1 mmHg for the respective doses[1].

A second study with 258 patients further confirmed these findings, showing linear decreases in diastolic blood pressure with increasing doses of CARDIZEM LA. The group mean changes in diastolic blood pressure were -2.6 mmHg for placebo, -1.9 mmHg for 120 mg, -5.4 mmHg for 180 mg, -6.1 mmHg for 300 mg, and -8.6 mmHg for 540 mg[4].

Mechanism of Action

Diltiazem, the active ingredient in CARDIZEM LA, works by inhibiting the influx of calcium ions into cardiac and vascular smooth muscle cells. This action results in arterial vasodilation, reduced myocardial oxygen demand, and decreased systemic blood pressure and heart rate. It also dilates coronary arteries, both epicardial and subendocardial, and inhibits spontaneous and ergonovine-induced coronary artery spasms[3][5].

Market Analysis

Market Size and Growth

The global diltiazem market, which includes CARDIZEM LA, is projected to grow significantly. As of 2021, the market size was estimated at US$ 369.95 million, and it is expected to reach US$ 832.51 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 12.3% during this period[2].

Driving Factors

The growth of the diltiazem market is driven by several factors, including the increasing incidence of cardiovascular diseases, particularly among the elderly population. Heart diseases such as hypertension, coronary artery disease, and heart failure are more prevalent in older individuals due to age-related changes in the cardiovascular system. The rising geriatric population worldwide is a significant driver of this market[2].

Product Type and Application Insights

The diltiazem market is segmented by product type into capsules, injections, and tablets. In 2021, the tablets segment held the largest share of the market, while the capsules segment is expected to witness the fastest CAGR during the forecast period. By application, the hypertension segment dominated the market in 2021, but the angina segment is expected to grow at the fastest CAGR in the coming years[2].

Regional Insights

The diltiazem market is analyzed across various regions, including North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America. Each region has its unique trends and factors influencing the market growth. Companies operating in this market focus on product innovations to meet evolving customer demands and maintain their brand presence globally[2].

Side Effects and Contraindications

While CARDIZEM LA is effective in managing angina and hypertension, it is associated with several side effects, including amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, and sexual difficulties. It is contraindicated in patients with sick sinus syndrome, second- or third-degree AV block, hypotension, and acute myocardial infarction with pulmonary congestion[1][4].

Key Players

The diltiazem market includes several key 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 focused on product innovations and strategic expansions to maintain their market share[2].

Future Projections

Market Growth

The diltiazem market is expected to continue growing due to the increasing prevalence of cardiovascular diseases and the aging population. However, the market growth may be hampered by the side effects associated with diltiazem and the availability of alternative treatments.

Emerging Trends

Companies in the diltiazem market are likely to focus on developing new formulations and delivery systems to enhance patient compliance and reduce side effects. The integration of technology, such as personalized medicine and digital health solutions, may also play a significant role in the future of this market.

Key Takeaways

• CARDIZEM LA has been shown to be effective in clinical trials for managing chronic stable angina and hypertension.
• The global diltiazem market is projected to grow at a CAGR of 12.3% from 2021 to 2028.
• The market growth is driven by the increasing incidence of cardiovascular diseases, particularly among the elderly population.
• Side effects and contraindications are significant considerations for the use of CARDIZEM LA.
• Key players in the market are focusing on product innovations and strategic expansions.

FAQs

What is CARDIZEM LA used for?

CARDIZEM LA is used for the management of chronic stable angina and hypertension. It works by dilating coronary and systemic arteries, reducing myocardial oxygen demand, and decreasing systemic blood pressure and heart rate[3][5].

What are the common side effects of CARDIZEM LA?

Common side effects include amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, and sexual difficulties[1][4].

How does diltiazem affect the body?

Diltiazem inhibits the influx of calcium ions into cardiac and vascular smooth muscle cells, leading to arterial vasodilation, reduced myocardial oxygen demand, and decreased systemic blood pressure and heart rate[3][5].

What is the projected market size of the diltiazem market by 2028?

The global diltiazem market is projected to reach US$ 832.51 million by 2028, growing at a CAGR of 12.3% from 2021[2].

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

The capsules segment is expected to witness the fastest CAGR during the forecast period, while the angina segment is expected to grow at the fastest CAGR in terms of application[2].

Sources

1. eMPR: Cardizem LA Prescription & Dosage Information.
2. The Insight Partners: Diltiazem Market Size, Share & Growth Analysis by 2028.
3. Synapse: Diltiazem Hydrochloride - Drug Targets, Indications, Patents.
4. FDA: Cardizem LA (diltiazem hydrochloride) tablet label.
5. DrugBank Online: Diltiazem: Uses, Interactions, Mechanism of Action.