CLINICAL TRIALS PROFILE FOR PLENDIL

All Clinical Trials for PLENDIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02232269 ↗	Coffee Interaction With the Antihypertensive Drug Felodipine	Completed	Lawson Health Research Institute	Phase 1	2012-02-01	Coffee is a globally popular beverage. More than half of the United States population spends an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for less than one day per week consumption in one survey. In the case of occasional consumption, coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups of coffee. A major active constituent in coffee is caffeine, which is the most widely used pharmacological substance in the world. Drug therapy plays a major role in the management of hypertension. However, the interaction between coffee or caffeine and blood pressure lowering drugs has been assessed in only three clinical studies that were reported more than three decades ago. We conducted a comprehensive interaction study involving a commonly ingested amount of a particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics were evaluated.
NCT02311530 ↗	Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2008-10-01	The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg) manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.
NCT02327247 ↗	Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2008-09-01	The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories, Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg) manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP Wilmington, DE 19850 in healthy, adult, male, human subjects under fasting condition.
NCT01238705 ↗	Combined Antihypertensive Therapy and Sexual Dysfunction	Unknown status	LanZhou University	Phase 4	2008-04-01	This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs. The researchers hypothesize that: 1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension. 2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels. 3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.

Clinical Trial Conditions for PLENDIL

Condition Name

Condition Name for PLENDIL
Intervention	Trials
Healthy	2
Food-Drug Interactions	1
Hypertension	1
Sexual Dysfunction	1

Condition MeSH

Condition MeSH for PLENDIL
Intervention	Trials
Malnutrition	1
Hypertension	1

Clinical Trial Locations for PLENDIL

Trials by Country

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Trials by Country for PLENDIL
Location	Trials
Canada	1
China	1

Clinical Trial Progress for PLENDIL

Clinical Trial Phase

Clinical Trial Phase for PLENDIL
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
N/A	2

Clinical Trial Status

Clinical Trial Status for PLENDIL
Clinical Trial Phase	Trials
Completed	3
Unknown status	1

Clinical Trial Sponsors for PLENDIL

Sponsor Name

Sponsor Name for PLENDIL
Sponsor	Trials
Ranbaxy Laboratories Limited	2
LanZhou University	1
Lawson Health Research Institute	1

Sponsor Type

Sponsor Type for PLENDIL
Sponsor	Trials
Other	2
Industry	2

Clinical Trials, Market Analysis, and Projections for PLENDIL (Felodipine)

Introduction

PLENDIL, also known as felodipine, is a calcium channel blocker used primarily for the treatment of hypertension. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Hypertension Studies

Clinical trials for PLENDIL have been extensive, involving over 800 patients in six placebo-controlled, dose-response studies. These studies evaluated the efficacy of both immediate-release and extended-release formulations of felodipine. The results showed dose-related decreases in both systolic and diastolic blood pressure, with significant reductions observed across various doses ranging from 2.5 mg to 20 mg per day[1][4].

Key Findings

• Blood Pressure Reduction: Felodipine administered once daily as monotherapy or in combination with beta blockers demonstrated substantial blood pressure control lasting for 24 hours.
• Pharmacokinetics: The extended-release formulation of felodipine showed a triexponential decline in plasma concentration, with mean disposition half-lives of 4.8 minutes, 1.5 hours, and 9.1 hours. The trough plasma concentrations were significantly lower than the EC50 needed for a half-maximal decline in blood pressure, supporting the use of extended-release formulations for once-daily dosing[1].
• Adverse Events: Common adverse events included peripheral edema, headache, and flushing, with peripheral edema being the most common reason for discontinuation of therapy[4].

Angina Studies

The FEMINA trial, a multicenter, randomized, double-blind study, evaluated the addition of felodipine to metoprolol versus replacing metoprolol with felodipine in patients with stable angina despite optimal beta blockade. The trial found that dual therapy with metoprolol and felodipine improved several exercise testing parameters, including time to 1 mm ST depression and rate pressure product, compared to metoprolol alone. However, replacing metoprolol with felodipine alone resulted in a worsening of these parameters[3].

Market Analysis

Current Market

PLENDIL is part of the broader antihypertensive drug market, which is a significant segment within the cardiovascular therapeutic area. The drug is indicated for lowering blood pressure and reducing the risk of fatal and non-fatal cardiovascular events such as strokes and myocardial infarctions[1][4].

Market Trends

The antihypertensive market is driven by the increasing prevalence of hypertension and the need for comprehensive cardiovascular risk management. While PLENDIL is not as widely discussed in terms of market growth as some other therapeutic areas like NSCLC, it remains a staple in the treatment of hypertension due to its efficacy and safety profile.

Projections and Future Outlook

Competition and Market Dynamics

The antihypertensive market is highly competitive, with numerous drugs available across different pharmacologic classes. PLENDIL faces competition from other calcium channel blockers, ACE inhibitors, ARBs, and beta blockers. However, its extended-release formulation and once-daily dosing regimen provide a competitive edge in terms of patient compliance and convenience[1][4].

Demographic and Age-Related Considerations

Felodipine's pharmacokinetics vary significantly with age, with elderly patients showing reduced clearance and higher AUCs compared to younger patients. This demographic trend is crucial for dosing adjustments and safety monitoring in older populations[1].

Potential Growth Areas

While the NSCLC market is projected to grow significantly due to the adoption of immunotherapies and targeted therapies, the antihypertensive market, including drugs like PLENDIL, is expected to maintain its stability. The increasing global prevalence of hypertension, particularly in aging populations, will continue to drive the demand for effective antihypertensive medications.

Challenges and Opportunities

One of the challenges for PLENDIL and similar drugs is the potential for generic competition, which can impact market share and revenue. However, the ongoing need for blood pressure management and the potential for combination therapies (as seen in the FEMINA trial) offer opportunities for continued relevance and innovation in the treatment of hypertension.

Key Takeaways

• Efficacy: PLENDIL has demonstrated significant blood pressure reductions in clinical trials, making it a valuable option for hypertension management.
• Pharmacokinetics: The extended-release formulation of felodipine allows for once-daily dosing, enhancing patient compliance.
• Safety: Common adverse events include peripheral edema, headache, and flushing, with careful monitoring needed, especially in elderly patients.
• Market: The antihypertensive market is competitive but stable, with PLENDIL maintaining its position due to its efficacy and convenience.
• Future Outlook: The drug will continue to be relevant due to the increasing prevalence of hypertension and the need for comprehensive cardiovascular risk management.

FAQs

What is PLENDIL used for?

PLENDIL (felodipine) is used for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and non-fatal cardiovascular events such as strokes and myocardial infarctions[1][4].

What are the common side effects of PLENDIL?

Common side effects include peripheral edema, headache, and flushing. Peripheral edema is the most common reason for discontinuation of therapy[4].

How does the extended-release formulation of PLENDIL work?

The extended-release formulation of felodipine allows for once-daily dosing, with a triexponential decline in plasma concentration and mean disposition half-lives of 4.8 minutes, 1.5 hours, and 9.1 hours[1].

Can PLENDIL be used in combination with other medications?

Yes, PLENDIL can be used in combination with other medications, such as beta blockers. The FEMINA trial demonstrated the benefits of combining felodipine with metoprolol in patients with stable angina[3].

How does age affect the pharmacokinetics of PLENDIL?

Elderly patients show reduced clearance and higher AUCs of felodipine compared to younger patients, necessitating careful dosing adjustments and safety monitoring[1].

Sources

1. PLENDIL EXTENDED-RELEASE TABLETS - FDA Label[1]
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData[2]
3. Addition of felodipine to metoprolol vs. replacement of metoprolol by felodipine in patients with angina pectoris despite adequate beta-blockade - FEMINA - American College of Cardiology[3]
4. Plendil (Felodipine): Side Effects, Uses, Dosage, Interactions - RxList[4]