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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR ADALAT


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All Clinical Trials for Adalat

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00137501 ↗ Two Dose Regimens of Nifedipine for the Management of Preterm Labor Terminated American University of Beirut Medical Center Phase 3 2003-05-01 Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
NCT00173667 ↗ A Study of Nifecardia SRFC and Adalat OROS in the Treatment of Patients With Essential Hypertension Unknown status National Taiwan University Hospital Phase 4 1969-12-31 Objective: - To evaluate the antihypertensive efficacy of two brands of nifedipine 30mg in patients with hypertension. - To assess the safety of 8 weeks of therapy with two brands of nifedipine 30mg in patients with hypertension. - To study flow-mediated dilatation and oxidative stress in nonsmoker with essential hypertension but without diabetes mellitus or dyslipidemia. Study Design: - Head-to-head, randomized and parallel design. - A total of 60 patients with a clinically confirmed diagnosis of hypertension will provide 30 available patients in each treatment group. - The drugs and dosage will be as follows: Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once daily (Adalat OROS, Bayer) Method: After washout period, the eligible patients will randomly be allocated to receive two brands of nifedipine 30 mg once daily. Each patient will receive two times of ambulatory blood pressure measurement (ABPM) at both entrance and final stages of the study. The patients will also undergo complete clinical evaluation. Therapy dosage will be started at a dose of nifedipine 30 mg once daily. Dosage will be adjusted if systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg by office measurement after 4 weeks of treatment. Nifedipine will be increased to 60 mg once daily. The Ambulatory blood pressure measurement will be set to take reading at 1-hour intervals during the 24 hours assessment. Physical examination included the measurement of heart rate and blood pressure. The value will be read on Visit 1 and 3-12 hours after the last dose of nifedipine. Routine laboratory test includes hematology, blood chemistry and urinalysis. Hematology test and fasting blood chemistry test will be measured immediately before the start of treatment and after 8 weeks' treatment or at time of discontinuation. Thiobarbituric acid-reactive substances (TBARS) in patient plasma were measured for oxidative stress and endothelium-dependent flow-mediated vasodilation will also be evaluated. Possible concomitant medication will remain constant throughout the study. The physician will question the patients as to their compliance at each visit. If compliance dose not reach 80%, the subject will be dropped out.
NCT00175682 ↗ Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study Completed University of British Columbia N/A 2004-12-01 Sexuality is a high rehabilitative priority for persons following a spinal cord injury (SCI). Sexual acts can lead to autonomic dysreflexia (AD), dangerous consequences such as a sudden increase in blood pressure, severe headache, sweating above the level of the lesion and low heart rate to name a few. Ejaculation in men can provoke these significant symptoms and therefore men and women may refrain from a sexual life and biological parenthood. Adalat is the most common antihypertensive used in fertility clinics to reduce the incidence of AD. It dramatically reduces blood pressure and, therefore, results in side effects such as dizziness, fatigue and weakness. The investigators hypothesize that Minipress® (prazosin HCL), a blood pressure medication, which has a slower and less abrupt suppressive effect on blood pressure, would be a safe, effective and more appropriate medication for use in the outpatient sperm retrieval clinic and potentially for private use.
NCT00223717 ↗ Treatment of Supine Hypertension in Autonomic Failure Completed Vanderbilt University Phase 1 2001-01-01 Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Adalat

Condition Name

Condition Name for Adalat
Intervention Trials
Hypertension 14
Essential Hypertension 2
Healthy 2
Bioequivalence 2
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Condition MeSH

Condition MeSH for Adalat
Intervention Trials
Hypertension 17
Essential Hypertension 3
Obstetric Labor, Premature 2
Renal Insufficiency, Chronic 2
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Clinical Trial Locations for Adalat

Trials by Country

Trials by Country for Adalat
Location Trials
United States 34
China 14
Japan 4
Korea, Republic of 4
Taiwan 2
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Trials by US State

Trials by US State for Adalat
Location Trials
Arkansas 2
Tennessee 2
North Dakota 2
Wisconsin 1
Utah 1
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Clinical Trial Progress for Adalat

Clinical Trial Phase

Clinical Trial Phase for Adalat
Clinical Trial Phase Trials
Phase 4 15
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Adalat
Clinical Trial Phase Trials
Completed 19
Unknown status 5
Recruiting 2
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Clinical Trial Sponsors for Adalat

Sponsor Name

Sponsor Name for Adalat
Sponsor Trials
Bayer 8
Vanderbilt University 2
University of Arkansas 2
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Sponsor Type

Sponsor Type for Adalat
Sponsor Trials
Other 86
Industry 18
NIH 1
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Adalat: Clinical Trials, Market Analysis, and Projections

Introduction to Adalat

Adalat, also known as nifedipine, is a calcium channel blocker used primarily to treat hypertension and angina. It is available in various formulations, including immediate release and extended release forms like Adalat CC and Adalat XL.

Clinical Trials Overview

Study 12716: Adalat XL vs Diltiazem

One significant clinical trial involving Adalat XL is the CARDINAL study, which compares the effects of Adalat XL and diltiazem on proteinuria and blood pressure in hypertensive diabetic patients. Here are the key points:

  • Study Design: This is a randomized, open-label, 2-arm parallel design comparator study.
  • Patient Criteria: Patients must be diagnosed with hypertension and type 2 diabetes, have proteinuria between 0.8g/day and 3.0g/day, and be on stable medication for diabetes and hypertension.
  • Treatment: After a 12-week run-in period on Avalide, patients are randomly assigned to either Adalat XL or Tiazac XC for 18 weeks.
  • Endpoints: The study aims to compare the change in proteinuria and blood pressure reduction to near-normal levels[1].

Procardia XL and Adalat CC Comparison

Another study compares the relative potency, 24-hour automated ambulatory blood pressure control (ABPM), and adverse event profiles of Procardia XL and Adalat CC. Here are the highlights:

  • Study Design: This is a crossover design study with a 4-week placebo period followed by six weeks of treatment with either Procardia XL or Adalat CC.
  • Dosage: Dosage is titrated weekly to achieve a diastolic blood pressure of less than 90 mmHg.
  • Endpoints: The study evaluates 24-hour ABPM and adverse events using the Naranjo scale[3].

Pharmacological Profile of Adalat CC

Dosage and Administration

Adalat CC is an extended-release formulation of nifedipine, designed to provide once-daily dosing. Here are some key points:

  • Dosage: Available in 30 mg, 60 mg, and 90 mg tablets.
  • Administration: Should be swallowed whole and taken on an empty stomach. It should not be administered with food, and tablets should not be chewed, divided, or crushed[4].

Pharmacokinetics

  • Elimination Half-Life: Approximately 7 hours, which is longer than the immediate release form.
  • Dose Proportionality: The area under the curve (AUC) is dose proportional, but peak plasma concentrations can vary significantly depending on the dosage form[4].

Interactions and Precautions

  • Beta-Blockers: Adalat CC can be well-tolerated when administered with beta-blockers.
  • Doxazosin: Blood pressure should be monitored when co-administered with doxazosin, and dose reduction of nifedipine may be necessary.
  • Digoxin: Digoxin levels should be monitored when initiating, adjusting, or discontinuing Adalat CC to avoid over- or under-digitalization[4].

Market Analysis and Projections

Current Market Position

Adalat, as a well-established calcium channel blocker, has a significant presence in the hypertension and angina treatment markets. Its extended-release formulations like Adalat CC and Adalat XL are particularly popular due to their convenience and efficacy.

Market Trends

The pharmaceutical market, including hypertension treatments, is influenced by several trends:

  • Technological Innovation: Advances in drug delivery systems, such as the osmotically active drug core in Procardia XL and the slow-release outer coat in Adalat CC, enhance patient compliance and efficacy[3].
  • Consumer Behavior: Patients are increasingly seeking medications with fewer side effects and easier dosing regimens, which extended-release formulations like Adalat CC can provide.
  • Personalization: There is a growing demand for personalized treatment plans, which may include tailored dosages and formulations of drugs like Adalat[5].

Financial Projections

While specific financial projections for Adalat are not readily available, the overall pharmaceutical market, particularly for hypertension treatments, is expected to grow. Here are some broader market trends:

  • Revenue Growth: The pharmaceutical industry, including segments related to hypertension and cardiovascular diseases, is expected to see significant revenue growth driven by increasing demand for effective treatments.
  • Competitive Landscape: Adalat competes with other calcium channel blockers and hypertension medications. Its market share can be influenced by the introduction of new drugs, generic alternatives, and changes in prescribing practices.

Example of Industry Growth

Adial Pharmaceuticals, though not directly related to Adalat, provides an example of the growth potential in the pharmaceutical sector. Adial Pharmaceuticals is forecasted to grow its earnings and revenue by 27.4% and 70.6% per annum, respectively, with EPS expected to grow by 51.9% per annum. This indicates a robust growth environment within the pharmaceutical industry[2].

Key Takeaways

  • Clinical Trials: Adalat XL is being compared to diltiazem in the CARDINAL study to assess its effects on proteinuria and blood pressure in diabetic patients.
  • Pharmacological Profile: Adalat CC offers extended-release benefits with a longer elimination half-life and dose-proportional AUC, but requires careful administration and monitoring for interactions.
  • Market Analysis: The market for hypertension treatments is growing, driven by technological innovations, changing consumer behaviors, and the need for personalized treatments.
  • Financial Projections: While specific projections for Adalat are not available, the broader pharmaceutical market is expected to see significant growth.

FAQs

What is the primary use of Adalat?

Adalat, or nifedipine, is primarily used to treat hypertension and angina.

What are the different formulations of Adalat?

Adalat is available in immediate release and extended release forms, such as Adalat CC and Adalat XL.

How does Adalat CC differ from Procardia XL?

Adalat CC and Procardia XL use different drug delivery systems. Adalat CC has a slow-release outer coat and a fast-release inner core, while Procardia XL uses an osmotically active drug core surrounded by a semipermeable membrane[3].

What are the potential interactions of Adalat CC with other medications?

Adalat CC can interact with beta-blockers, doxazosin, and digoxin, among others. Blood pressure and digoxin levels should be monitored when co-administered[4].

What are the market trends influencing the demand for Adalat?

The demand for Adalat is influenced by technological innovations in drug delivery, evolving consumer behaviors, and the need for personalized treatment plans[5].

Sources

  1. ClinicalTrials.bayer.com: Diabetic Nephropathies, Hypertension | Study 12716 | Bayer
  2. SimplyWall.st: Adial Pharmaceuticals (NasdaqCM:ADIL) Stock Forecast & Analyst ...
  3. Academic.oup.com: Procardia XL, Adalat CC, 24-hour Automated Blood Pressure ...
  4. Accessdata.fda.gov: Adalat CC (nifedipine) tablets label
  5. BIA.com: 2025 Local Ad Market: New Report Examines Top 10 Trends ...

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