CLINICAL TRIALS PROFILE FOR PROCARDIA

All Clinical Trials for Procardia

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000102 ↗	Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets	Completed	National Center for Research Resources (NCRR)	Phase 1/Phase 2	1969-12-31	This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT00593463 ↗	Drug Discrimination in Methadone-Maintained Humans Study 1	Completed	University of Arkansas	Phase 1	2006-09-01	This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.
NCT01348880 ↗	Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study	Completed	GlaxoSmithKline	Phase 1	2011-05-01	The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.

Clinical Trial Conditions for Procardia

Condition Name

Condition Name for Procardia
Intervention	Trials
Preeclampsia	3
Hypertension in Pregnancy	2
Healthy Volunteers	1

Condition MeSH

Condition MeSH for Procardia
Intervention	Trials
Pre-Eclampsia	4
Hypertension	2
Obstetric Labor, Premature	2

Clinical Trial Locations for Procardia

Trials by Country

Trials by Country for Procardia
Location	Trials
United States	11

Trials by US State

Trials by US State for Procardia
Location	Trials
Tennessee	3
Wisconsin	1
New York	1
California	1
Missouri	1

Clinical Trial Progress for Procardia

Clinical Trial Phase

Clinical Trial Phase for Procardia
Clinical Trial Phase	Trials
Phase 4	2
Phase 1/Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Procardia
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Withdrawn	2

Clinical Trial Sponsors for Procardia

Sponsor Name

Sponsor Name for Procardia
Sponsor	Trials
The University of Texas Health Science Center, Houston	1
University of Tennessee Medical Center	1
St. Louis University	1

Sponsor Type

Sponsor Type for Procardia
Sponsor	Trials
Other	14
Industry	3
U.S. Fed	1

Procardia (Nifedipine): Clinical Trials, Market Analysis, and Projections

Introduction

Procardia, also known as nifedipine, is a calcium channel blocker widely used in the management of chronic stable angina and hypertension. Here, we will delve into the current clinical trials landscape, market analysis, and future projections for this drug.

Clinical Trials and Usage

Indications and Efficacy

Procardia XL (nifedipine extended-release tablets) is indicated for the management of chronic stable angina and hypertension. It is particularly useful in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates, or who cannot tolerate these agents[1][4].

Clinical Trials Overview

Clinical trials involving nifedipine have shown its efficacy in various cardiovascular conditions. For instance, over 1000 patients in both controlled and open trials with Procardia XL Extended Release Tablets were evaluated for hypertension and angina, demonstrating the drug's safety and effectiveness[4].

Safety and Adverse Effects

While nifedipine is generally well-tolerated, clinical trials have noted rare but significant elevations in certain enzymes and occasional reports of allergic hepatitis. Common adverse effects include edema, headache, fatigue, dizziness, constipation, and nausea[1][4].

Market Analysis

Market Size and Growth

The nifedipine market is projected to grow significantly over the coming years. By 2027, the market size is estimated to reach $1.7 billion, growing at a CAGR of 4.1% during the forecast period 2022-2027[2]. Another report suggests that the global nifedipine market will grow at an approximate CAGR of 8.4% from 2024 to 2032, reaching a market size of $2,254.9 million by 2032[5].

Geographical Distribution

North America currently holds the largest share of the global nifedipine market and is expected to grow at a CAGR of 8.5% over the forecast period. However, the Asia-Pacific region is poised to offer lucrative growth opportunities due to the increasing prevalence of chronic illnesses and improving healthcare infrastructure[2][5].

Distribution Channels

The nifedipine market is segmented by distribution channels, including hospital pharmacies, medical centers, and retail pharmacies. The hospital pharmacy segment is significant, but retail pharmacies are also expected to grow, especially in regions with expanding healthcare access[2].

Market Drivers

Increasing Prevalence of Chronic Illnesses

The growing prevalence of hypertension, angina, and other cardiovascular diseases is a major driver for the nifedipine market. Poor lifestyle choices, such as obesity, lack of exercise, and increased consumption of junk food and alcohol, contribute to these health issues, thereby increasing the demand for nifedipine[2][5].

Post-COVID-19 Health Trends

The COVID-19 pandemic has led to an increase in acute and chronic health abnormalities, further boosting the demand for calcium channel blockers like nifedipine. This trend is expected to continue, driving market growth[2][5].

Market Challenges

Side Effects and Health Concerns

Despite its efficacy, nifedipine is associated with several side effects, which can hamper market growth. These include rare but significant elevations in certain enzymes, allergic hepatitis, and other adverse effects[1][2].

Future Projections

Expanding Applications

Nifedipine is not only used for hypertension and angina but also for other conditions such as preterm labor, Prinzmetal angina, and Raynaud’s phenomenon. The expanding use of nifedipine in these areas is expected to further drive market growth[2].

Technological Advancements

The development of extended-release formulations like Procardia XL has improved the pharmacokinetic profile of nifedipine, providing constant drug delivery over 24 hours. Such technological advancements are likely to enhance patient compliance and treatment outcomes, contributing to market expansion[4].

Key Takeaways

• Growing Market Size: The nifedipine market is projected to reach $1.7 billion by 2027 and $2,254.9 million by 2032.
• Geographical Growth: North America is the largest market, but Asia-Pacific is expected to be the fastest-growing region.
• Increasing Demand: The growing prevalence of chronic illnesses and post-COVID-19 health trends are driving the demand for nifedipine.
• Technological Advancements: Extended-release formulations like Procardia XL are improving treatment outcomes and patient compliance.
• Side Effects: Despite its efficacy, nifedipine is associated with several side effects that could impact market growth.

FAQs

What are the primary indications for Procardia (nifedipine)?

Procardia is primarily indicated for the management of chronic stable angina and hypertension.

What are the common side effects of Procardia?

Common side effects include edema, headache, fatigue, dizziness, constipation, and nausea.

How is the nifedipine market expected to grow in the future?

The nifedipine market is expected to grow at a CAGR of 4.1% from 2022 to 2027 and at an approximate CAGR of 8.4% from 2024 to 2032.

Which region holds the largest share of the global nifedipine market?

North America currently holds the largest share of the global nifedipine market.

What are the main drivers for the growth of the nifedipine market?

The main drivers include the increasing prevalence of chronic illnesses, post-COVID-19 health trends, and technological advancements in drug formulations.

Sources

1. Pfizer Medical Information: PROCARDIA® XL (nifedipine extended release tablets) Patient Information.
2. IndustryARC: Nifedipine Market Size Report, 2022-2027.
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
4. FDA: PROCARDIA XL - accessdata.fda.gov.
5. Straits Research: Nifedipine Market Size, Share, Trends, Forecast Report 2032.