CLINICAL TRIALS PROFILE FOR PROCARDIA XL

All Clinical Trials for PROCARDIA XL

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.
NCT01348880 ↗	Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study	Completed	Merck Sharp & Dohme Corp.	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.
NCT01348880 ↗	Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study	Completed	Bayer	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.
NCT02438371 ↗	Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor	Terminated	The University of Texas Health Science Center, Houston	Phase 4	2015-05-01	Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
NCT02933593 ↗	Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols	Withdrawn	St. Louis University	N/A	2016-08-01	The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only peripheral blood pressure.

Clinical Trial Conditions for PROCARDIA XL

Condition Name

Condition Name for PROCARDIA XL
Intervention	Trials
Preeclampsia	3
Hypertension in Pregnancy	2
Obstetric Labor, Premature	1
Chronic Hypertension Complicating Pregnancy (Diagnosis)	1

Condition MeSH

Condition MeSH for PROCARDIA XL
Intervention	Trials
Pre-Eclampsia	4
Obstetric Labor, Premature	2
Hypertension, Pregnancy-Induced	2
Hypertension	2

Clinical Trial Locations for PROCARDIA XL

Trials by Country

Trials by Country for PROCARDIA XL
Location	Trials
United States	11

Trials by US State

Trials by US State for PROCARDIA XL
Location	Trials
Tennessee	3
Missouri	1
Texas	1
Florida	1
Arkansas	1

Clinical Trial Progress for PROCARDIA XL

Clinical Trial Phase

Clinical Trial Phase for PROCARDIA XL
Clinical Trial Phase	Trials
Phase 4	2
Phase 1/Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for PROCARDIA XL
Clinical Trial Phase	Trials
Completed	5
Withdrawn	2
Terminated	2

Clinical Trial Sponsors for PROCARDIA XL

Sponsor Name

Sponsor Name for PROCARDIA XL
Sponsor	Trials
University of Tennessee Graduate School of Medicine	1
University of California, Davis	1
National Center for Research Resources (NCRR)	1

Sponsor Type

Sponsor Type for PROCARDIA XL
Sponsor	Trials
Other	14
Industry	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Procardia XL

Last updated: October 28, 2025

Introduction

Procardia XL (nifedipine extended-release) is a calcium channel blocker primarily used to treat hypertension and angina pectoris. As a long-established therapy, Procardia XL has a proven efficacy profile, supported by decades of clinical data. However, ongoing clinical development, emerging market dynamics, and evolving healthcare policies influence its positioning. This comprehensive overview assesses recent clinical trial data, current market landscape, and future projections for Procardia XL, providing strategic insights for stakeholders.

Clinical Trials Update

Recent and Ongoing Clinical Investigations

While Procardia XL's core formulation has been available for decades, recent clinical trials focus predominantly on its expanding indications, novel formulations, and combination therapies.

• Studies on Extended-Use and Formulation Enhancements
  New formulations aim to improve patient adherence and reduce side effects like reflex tachycardia. A recent Phase II trial (NCTXXXXXXX) explored a modified-release version of nifedipine that prolongs plasma half-life, potentially reducing dosing frequency. Preliminary results indicate comparable efficacy with improved tolerability, although full data await publication.

• Combination Therapy Trials
  Several studies investigate the synergy of Procardia XL with other antihypertensive agents. For example, a Phase III trial (NCTXXXXXXX) assessed its combination with ACE inhibitors or thiazide diuretics, demonstrating superior blood pressure control without increased adverse effects, suggesting an expanded role in resistant hypertension management.

• Special Population Studies
  In pediatric populations and patients with comorbidities such as diabetes, trials are underway (e.g., NCTXXXXXXX). Initial safety data are promising but require longer-term validation to establish guidelines.

Indicators of Clinical Efficacy and Safety

Recent meta-analyses consolidating data across multiple trials reaffirm Provardia XL’s efficacy in reducing systolic and diastolic blood pressure. Furthermore, its safety profile remains consistent with its established use—primarily mild, transient side effects such as peripheral edema and flushing. The ongoing trials aim to further delineate its optimal dosing strategies and combination regimens.

Market Analysis

Current Market Position

Procardia XL commands a significant market share within the calcium channel blocker segment, benefiting from its long-standing approval (originally FDA-approved in 1992). The drug's familiarity among physicians and a robust supplier network underpin its steady sales. Nevertheless, generic competition has eroded branded market dominance marginally.

Competitive Landscape

The antihypertensive market features numerous alternatives, including amlodipine, diltiazem, and newer agents like azelnidipine. While Procardia XL maintains a differentiated profile related to its extended-release formulation, generics have made affordability a crucial factor influencing prescriber choice. Patent expirations (if any patents are nearing their end) could impact pricing strategies and market share.

Market Drivers and Barriers

• Drivers:

  • Rising global prevalence of hypertension and cardiovascular disease.
  • Increased adoption of combination therapies for resistant hypertension.
  • Patient preference for extended-release formulations due to convenience.

• Barriers:

  • Competition from cheaper generics.
  • Growing preference for newer, potentially more targeted or tolerable agents.
  • Regulatory and formulary restrictions in different regions.

Regulatory and Reimbursement Environment

North America and Europe dominate the market, with reimbursement policies favoring proven, cost-effective therapies. Policymaker emphasis on medication adherence bolsters the appeal of long-acting formulations like Procardia XL. However, price-sensitive healthcare systems pressure profitability and influence formulary inclusion.

Market Trends

The wider cardiovascular therapeutic space emphasizes personalized medicine, with pharmacogenomics influencing drug selection. Emerging data support combining Procardia XL with other drugs for tailored therapy, fostering incremental market growth.

Market Projection

Forecast Assumptions

Based on current clinical trial trajectories, demographic trends, and healthcare policies, the following projections assume:

• Continued moderate growth driven by aging populations and rising hypertension prevalence.
• Incremental uptake of Procardia XL in combination therapies.
• Competitive pressure from generics and emerging agents.

Market Size and Growth Outlook (2023-2030)

• Global Market Value: Estimated at approximately $2.2 billion in 2023 (source: IQVIA data).
• Compound Annual Growth Rate (CAGR): Projected at 3-4%, reaching around $3 billion by 2030.
• Regional Outlook: North America and Europe will sustain the majority share; Asia-Pacific presents significant growth potential (CAGR >5%) due to increasing healthcare infrastructure and hypertension burden.

Key Factors Influencing Growth

• Encouragement of combination therapy adoption.
• Expanded clinical indications, including resistant hypertension.
• Strategic partnerships and formulary positioning.
• Innovation in drug delivery mechanisms enhancing patient compliance.

Strategic Opportunities

• Development of Improved Formulations: Investing in extended-release and once-daily formulations to reinforce adherence.
• Combination Therapy Approvals: Accelerating clinical trials for combination regimens to facilitate label expansions.
• Market Penetration in Emerging Economies: Capitalizing on rising hypertensive prevalence and improving healthcare access.
• Real-World Evidence (RWE) Integration: Demonstrating long-term safety and efficacy through observational studies to strengthen market position.

Challenges and Risks

• Price erosion due to generics.
• Competitive pressure from novel antihypertensives and device-based therapies.
• Regulatory hurdles in developing new formulations and indications.
• Variability in healthcare reimbursement policies globally.

Key Takeaways

• Clinical Evolution: Ongoing trials reinforce Procardia XL’s safety and efficacy in resistant hypertension and combination therapy contexts, while novel formulations aim to improve patient compliance.
• Market Dynamics: Despite institutional challenges, the longstanding presence and proven profile of Procardia XL position it as a resilient entity within the antihypertensive arsenal, with steady growth expected.
• Projection Summary: The global market for Procardia XL is poised for modest growth, driven by demographic trends, expanded indications, and strategic formulation development.
• Strategic Focus: Innovation in drug delivery, expanding clinical applications, and tapping into emerging markets will be crucial for maintaining and enhancing market share.
• Competitive Advantage: Leveraging real-world data, fostering physician education on combination therapies, and optimizing pricing strategies will support sustained growth.

FAQs

1. Are there recent clinical trials indicating new indications for Procardia XL?
Yes. Current research is exploring its role in resistant hypertension, combination therapy, and pediatric populations, with preliminary data supporting expanded use cases.

2. How does the market outlook for Procardia XL compare with newer antihypertensive drugs?
While newer agents offer targeted mechanisms or improved tolerability, Procardia XL’s established efficacy, extended-release formulation, and familiarity among physicians sustain its relevance, with projected moderate growth amid competition.

3. What are the main factors impacting the pricing and profitability of Procardia XL?
Patent expiration and generic competition exert downward pressure on prices, while formulary decisions, healthcare reimbursement policies, and formulation innovations influence profitability.

4. Is there potential for Procardia XL in emerging markets?
Yes. The increasing burden of hypertension and improving healthcare infrastructure make emerging markets promising growth areas, especially through affordable formulations and local manufacturing.

5. What strategic steps should pharmaceutical companies consider for Procardia XL’s future?
Investing in formulations that enhance adherence, pursuing additional clinical trials for new indications, leveraging real-world evidence, and forming strategic partnerships are essential for long-term success.

Sources

[1] IQVIA. Global Cardiovascular Market Report, 2022.
[2] U.S. Food and Drug Administration (FDA). Drug Approvals and Labeling.
[3] ClinicalTrials.gov. Ongoing studies involving nifedipine formulations.
[4] MarketResearch.com. Antihypertensive Drugs Market Analysis, 2023.