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.
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.

Clinical Trial Conditions for PROCARDIA

Condition Name

Condition Name for PROCARDIA
Intervention	Trials
Preeclampsia	3
Hypertension in Pregnancy	2
Obesity, Morbid	1
Obstetric Labor, Premature	1

Condition MeSH

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Withdrawn	2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

Clinical Trial Sponsors for PROCARDIA

Sponsor Name

Sponsor Name for PROCARDIA
Sponsor	Trials
Icahn School of Medicine at Mount Sinai	1
BioPharma Services, Inc	1
Medical College of Wisconsin	1

Sponsor Type

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

Last updated: May 3, 2026

Procardia (Nifedipine): Clinical-Development Update, Market Status, and Forward Projection

What is Procardia and where does it sit in the current development landscape?

Procardia is a brand of nifedipine, a calcium-channel blocker used for cardiovascular indications including angina, hypertension, and related ischemic heart disease. In the US, Procardia is the immediate-release nifedipine brand; Procardia XL is an extended-release formulation. Nifedipine is an established, off-patent small molecule with a long commercial history, so “clinical trials” today are dominated by post-marketing pharmacovigilance, formulation-bioequivalence, and registry or observational studies, not new late-stage registrational programs.

Clinical trials update (practical status)

• Current pipeline behavior: For older, off-patent small molecules like nifedipine, new clinical activity is usually concentrated in:
  • Bioequivalence studies for generics and authorized generics
  • Real-world evidence (RWE) studies on effectiveness/safety patterns
  • Regulatory submissions tied to manufacturing changes
• Registrational novelty expectation: For Procardia, no brand-sponsored Phase 3 program is typically expected because active ingredient patent protection has long expired and multiple generic equivalents exist.

What indications matter for market analysis of Procardia?

Nifedipine is used in multiple cardiovascular settings. For market sizing and forecasting, the addressable demand concentrates on:

• Hypertension management (including patients who are substituted across formulary classes)
• Angina (including chronic stable angina where dosing regimens include immediate- or extended-release calcium-channel blockers)
• Other off-label or guideline-supported uses depending on region and payer policies

The economic behavior of the product is driven less by new clinical efficacy claims and more by:

• Generic substitution rates
• Formulary access and tier placement
• Switching between immediate- vs extended-release products
• Dosing frequency and adherence impact

How is the market currently structured for Procardia (brand vs generics)?

Because nifedipine is an off-patent molecule, the brand’s commercial outcome depends on residual brand positioning and contract pricing rather than patent-protected exclusivity. In most mature markets:

• Generic nifedipine dominates volume
• Brand share is sustained only when payers keep brand on formularies and pricing remains competitive versus generics
• Extended-release demand often shifts toward products with stable reimbursement and preferred formulary status

This market structure typically creates a forecast pattern:

• Low single-digit annual brand decline or stagnation when brand is retained for formulary and supply stability
• Faster decline if payer formularies remove brand preference and expand generic substitution

What do proximate regulatory and label structures imply for demand stability?

Procardia is a well-characterized, long-standing therapy. That label stability supports:

• Continued prescribing where it fits clinical workflow
• Ongoing clinical use by practitioners familiar with dosing and adverse effect monitoring

But that same stability reduces sponsor incentives to run new pivotal trials. Demand remains linked to the routine cardiovascular care cycle rather than new evidence.

What is the clinical safety profile that shapes uptake and monitoring costs?

Nifedipine adverse effects drive both clinician behavior and payer scrutiny. Common safety considerations include:

• Peripheral edema
• Headache
• Flushing
• Hypotension (dose-related)
• Dizziness

For forecasting, this safety profile matters because it impacts:

• Patient persistence and dose modification
• Adverse-event-driven switching between agents (or between immediate- vs extended-release)

How do compliance and dosing form factor into market projections?

Procardia immediate-release dosing can have adherence friction relative to extended-release regimens depending on patient workflow and titration schedules. That matters because:

• Payers and prescribers often prefer dosing that reduces clinic visits and missed doses
• Extended-release products can win share when they align better with simplified daily regimens

So market projection is typically more resilient for the extended-release brand/formulations than the immediate-release brand where prescribers migrate to longer-acting options.

Clinical trials update: what to expect next (time-horizon view)

Over the next 12 to 36 months, “clinical trials” for nifedipine brands typically look like:

• Additional bioequivalence or bridging studies tied to formulation/manufacturing changes
• Post-marketing observational studies in specific populations (renal impairment, elderly, comorbid cardiovascular disease)
• Pharmacovigilance updates and label maintenance rather than new efficacy endpoints

For business planning, the key point is that these trials usually do not expand indication boundaries or change standard-of-care; they mainly sustain market access and regulatory compliance.

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Market Analysis and Projection Framework for Procardia

What are the market drivers and constraints?

Primary demand drivers

• Persistent prevalence of hypertension and angina
• Long-term acceptability of nifedipine in cardiovascular pharmacotherapy
• Existing prescriber familiarity and established dosing protocols

Primary supply and price drivers

• Generic competition and ongoing entry/re-entry from multiple manufacturers
• Contracting dynamics: rebates, formulary placement, and switching incentives
• Supply chain stability and manufacturing scale

Primary utilization constraints

• Adverse event profile leading to dose adjustments or class switching
• Competition from other calcium-channel blockers and combination regimens that can outperform on tolerance and dosing convenience

Base-case commercial outlook (brand-level)

For a mature off-patent molecule brand, the base-case forecast typically follows:

• Volume: modest erosion due to generic substitution and formulary pressure
• Revenue: held up only when pricing and rebates counteract unit volume decline
• Share: gradually declines unless the brand maintains a formulary position or benefits from contractual arrangements

Projections (directional)

A defensible directional projection for Procardia over the next 3 years is:

• Units: downward trend driven by generic substitution
• Net revenue: flattish-to-declining depending on price concessions and rebate dynamics
• Formulation shift: gradual preference for extended-release where it is favored by payers and clinicians

The projection is shaped by the molecule’s patent status and the market’s mature generic structure, which suppresses upside from new clinical evidence.

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Comparative Positioning: Procardia vs typical nifedipine generic dynamics

How does brand risk compare to similar older CCB brands?

For older CCB brands based on off-patent molecules, the brand’s competitive risks are usually:

• Formulary removal events (one step down to a cheaper tier or full exclusion)
• Automated substitution at the pharmacy counter
• Price compression after generic contract tightening

The upside levers are limited:

• Niche patient stabilization on the brand
• Differences in excipient profile or tolerability if supported by practical experience
• Contract rebates that keep the brand “good enough” relative to generics

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Actionable Implications for R&D and Investment Use-Cases

What does this mean for new development strategy tied to Procardia?

If the goal is to build a new product line around nifedipine (or to defend a brand), the most commercially meaningful pathways are:

• Novel formulation (once-daily or adherence-optimized versions with differentiated release profiles)
• Targeted clinical repositioning only if it can show differentiated outcomes or tolerance in a specific subpopulation
• Market access engineering (contracting and formulary retention) because clinical differentiation alone is unlikely to counter generic pricing pressure for the base molecule

What does this mean for market timing?

• Late-stage trials are not a realistic lever for short-term brand revenue growth for off-patent nifedipine.
• The near-term value is in channel execution and access rather than new efficacy claims.

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Key Takeaways

• Procardia (nifedipine) is a mature, off-patent therapy where “clinical trials” activity is typically post-marketing, bioequivalence, and observational rather than new registrational Phase 3 programs.
• The brand market outcome is dominated by generic substitution, formulary decisions, and contract pricing rather than new clinical evidence.
• Forward projection for brand-level performance is modest erosion or flat-to-declining revenue over 12 to 36 months, with formulation preferences (immediate vs extended-release) shaping utilization patterns.
• Commercial leverage shifts toward market access and lifecycle execution; R&D differentiation must come from formulation or clinically differentiated subpopulation strategy to matter against pervasive generic competition.

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FAQs

1. Is Procardia currently undergoing late-stage clinical development?
   For a long-established off-patent molecule like nifedipine, ongoing activity is typically non-registrational (bioequivalence, observational studies, pharmacovigilance) rather than brand-sponsored Phase 3 for new indications.

2. What drives Procardia demand most: clinical outcomes or reimbursement?
   Reimbursement and contracting typically dominate because multiple generic nifedipine products meet the same therapeutic need, compressing brand pricing power.

3. Does extended-release nifedipine generally perform better than immediate-release for brand retention?
   Often, yes, because extended-release dosing can align better with adherence and payer preference, which supports steadier utilization.

4. What safety issues most influence switching away from nifedipine?
   Peripheral edema, hypotension, and headache can drive dose modification or class switching, affecting persistence and net utilization.

5. What is the most realistic short-term growth path for a Procardia-like product?
   Contracting and formulary placement plus practical differentiation (e.g., formulation advantages) are more realistic than new efficacy claims.

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References

[1] FDA. Procardia (nifedipine) drug label. U.S. Food and Drug Administration.
[2] FDA. Procardia XL (nifedipine extended-release) drug label. U.S. Food and Drug Administration.
[3] WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD index for nifedipine (C08CA05). World Health Organization.
[4] PubMed. Nifedipine clinical studies and real-world evidence (search results for observational and pharmacovigilance literature). National Library of Medicine.