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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR PROCAINAMIDE HYDROCHLORIDE


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All Clinical Trials for Procainamide Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed University of Washington Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000518 ↗ Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1985-07-01 To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better method for selecting effective long-term antiarrhythmic drug therapy in patients with sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden death.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Procainamide Hydrochloride

Condition Name

Condition Name for Procainamide Hydrochloride
Intervention Trials
Atrial Fibrillation 5
Cardiovascular Diseases 3
Arrhythmia 3
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Condition MeSH

Condition MeSH for Procainamide Hydrochloride
Intervention Trials
Arrhythmias, Cardiac 5
Atrial Fibrillation 5
Tachycardia 4
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Clinical Trial Locations for Procainamide Hydrochloride

Trials by Country

Trials by Country for Procainamide Hydrochloride
Location Trials
Canada 7
Spain 5
United States 3
Turkey 1
Germany 1
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Trials by US State

Trials by US State for Procainamide Hydrochloride
Location Trials
Pennsylvania 1
New York 1
Tennessee 1
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Clinical Trial Progress for Procainamide Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Procainamide Hydrochloride
Clinical Trial Phase Trials
Phase 4 5
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Procainamide Hydrochloride
Clinical Trial Phase Trials
Completed 7
Withdrawn 4
Terminated 2
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Clinical Trial Sponsors for Procainamide Hydrochloride

Sponsor Name

Sponsor Name for Procainamide Hydrochloride
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 4
University of Pittsburgh 2
Jeffrey Moak 1
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Sponsor Type

Sponsor Type for Procainamide Hydrochloride
Sponsor Trials
Other 21
NIH 4
Industry 1
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Procainamide Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Procainamide Hydrochloride

Procainamide hydrochloride is an antiarrhythmic medication used primarily for the treatment of life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Use and Indications

Procainamide hydrochloride is indicated for the treatment of documented ventricular arrhythmias that are deemed life-threatening by a physician. It is not recommended for use in lesser arrhythmias due to its proarrhythmic effects. The initiation of procainamide treatment should be carried out in a hospital setting to monitor potential adverse reactions[1].

Clinical Trials and Efficacy

One significant clinical trial, the PROCAMIO study, compared the efficacy and safety of intravenous procainamide and amiodarone in the acute treatment of well-tolerated ventricular tachycardia. The study found that procainamide was associated with fewer major cardiac adverse events and a higher proportion of tachycardia termination within 40 minutes compared to amiodarone. Specifically, tachycardia terminated within 40 minutes in 67% of patients treated with procainamide versus 38% treated with amiodarone[3].

Safety Profile

The PROCAMIO study also highlighted the safety profile of procainamide. It showed that procainamide patients experienced fewer adverse events within the first 40 minutes and the subsequent 24 hours compared to those treated with amiodarone. This suggests that procainamide may be a safer option for acute treatment of ventricular tachycardia[3].

Adverse Reactions and Monitoring

Procainamide hydrochloride can cause serious hematological disorders, including agranulocytosis, bone marrow depression, neutropenia, hypoplastic anemia, and thrombocytopenia. These events are rare but can be fatal, occurring in approximately 0.5% of patients. It is crucial to monitor complete blood counts, including white cell, differential, and platelet counts, at weekly intervals for the first three months of therapy and periodically thereafter[1].

Dosage and Administration

Procainamide hydrochloride can be administered intravenously or intramuscularly. Intravenous administration can produce therapeutic levels within minutes, while intramuscular injection results in peak plasma levels within 15 to 60 minutes. For maintenance, a dilute intravenous infusion at a concentration of 2 mg/mL can be used, administered at 1 to 3 mL/minute[1][4].

Market Analysis

The global procainamide hydrochloride market has experienced significant growth in recent years and is projected to continue this trend from 2023 to 2031. Here are some key points from the market analysis:

Market Size and Forecast

The procainamide hydrochloride market is expected to reach substantial values by 2031, driven by increasing demand for effective antiarrhythmic treatments. The market is segmented by type (injection and oral), application (hospital, clinic, and others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][5].

Key Players

Major players in the procainamide hydrochloride market include Novartis, Pfizer, IDT Australia, ANI Pharmaceuticals, China Resources Double-crane Pharmaceutical, and Shanghai Sine Pharmaceutical Laboratories. These companies play a crucial role in the production and distribution of procainamide hydrochloride, contributing to the market's growth[5].

Market Dynamics

The market dynamics are influenced by several factors, including drivers such as the increasing prevalence of cardiac arrhythmias, advancements in healthcare infrastructure, and the need for effective antiarrhythmic medications. However, the market also faces restraints such as the potential for serious adverse reactions and the availability of alternative treatments[2].

Market Segmentation

The procainamide hydrochloride market is segmented based on several criteria:

By Type

  • Injection: This is the most common form of procainamide hydrochloride administration, particularly for acute treatments.
  • Oral: Oral forms are used for long-term maintenance of arrhythmia control[2].

By Application

  • Hospital: Hospitals are the primary setting for the administration of procainamide hydrochloride due to the need for close monitoring.
  • Clinic: Clinics may also use procainamide hydrochloride for outpatient treatments.
  • Others: This includes other healthcare settings such as emergency services and home care[2].

By Region

The market is analyzed across various geographical regions, each with its own growth prospects and challenges. North America and Europe are significant markets due to advanced healthcare systems, while the Asia-Pacific region is expected to show rapid growth due to increasing healthcare expenditure and a large patient population[2].

Projections and Future Outlook

The procainamide hydrochloride market is projected to experience robust growth from 2023 to 2031. This growth is driven by several factors:

Increasing Prevalence of Cardiac Arrhythmias

The rising incidence of cardiac arrhythmias, particularly in aging populations, is expected to drive the demand for effective antiarrhythmic medications like procainamide hydrochloride.

Advancements in Healthcare

Improvements in healthcare infrastructure and the availability of advanced diagnostic tools will enhance the detection and treatment of arrhythmias, further boosting the market.

Regulatory Support

Regulatory support for the development and approval of antiarrhythmic drugs will also contribute to the market's growth.

Key Takeaways

  • Clinical Efficacy: Procainamide hydrochloride is effective in treating life-threatening ventricular arrhythmias with a favorable safety profile compared to other antiarrhythmic agents like amiodarone.
  • Market Growth: The global procainamide hydrochloride market is expected to grow significantly from 2023 to 2031, driven by increasing demand and advancements in healthcare.
  • Key Players: Major pharmaceutical companies such as Novartis, Pfizer, and others play a crucial role in the market.
  • Segmentation: The market is segmented by type, application, and geographical region, each with its own growth prospects.

FAQs

What are the primary indications for procainamide hydrochloride?

Procainamide hydrochloride is primarily indicated for the treatment of documented ventricular arrhythmias that are life-threatening.

What are the potential adverse reactions of procainamide hydrochloride?

Procainamide hydrochloride can cause serious hematological disorders, including agranulocytosis, bone marrow depression, neutropenia, hypoplastic anemia, and thrombocytopenia.

How is procainamide hydrochloride administered?

Procainamide hydrochloride can be administered intravenously or intramuscularly, with intravenous administration producing therapeutic levels within minutes.

What is the projected growth of the procainamide hydrochloride market?

The market is expected to experience robust growth from 2023 to 2031, driven by increasing demand and advancements in healthcare.

Who are the major players in the procainamide hydrochloride market?

Major players include Novartis, Pfizer, IDT Australia, ANI Pharmaceuticals, China Resources Double-crane Pharmaceutical, and Shanghai Sine Pharmaceutical Laboratories.

Sources

  1. Drugs.com: Procainamide: Package Insert / Prescribing Information - Drugs.com
  2. MarketResearchIntellect: Procainamide Hydrochloride Market Size, Scope And Forecast Report
  3. PubMed: The PROCAMIO study
  4. Pfizer Medical Information: Procainamide Hydrochloride Injection, USP Dosage and Administration
  5. Valuates Reports: Procainamide Hydrochloride - Market, Report Size, Worth, Revenue

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