CLINICAL TRIALS PROFILE FOR TRANDATE HCT

All Clinical Trials for Trandate Hct

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02050529 ↗	Randomized Controlled Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.	Completed	Dow University of Health Sciences	Phase 2	2012-10-01	Severe Hypertension in pregnancy demands urgent treatment because of high mortality & morbidity in obstetric patients. Hydralazine, the most commonly used agent, causes sudden hypo tension and tachycardia. Labetalol because of combined α and β blocking effects lacks these side effects. Most recent Cochrane systematic review on use of anti hypertensive drugs in pregnancy related hypertension, could include only four trials of comparison of Hydralazine with Labetalol. Three out of total 4, had sample size ranging from 20-60 obstetric, with total sample size ranging from 19-30. Only 2 trials reported severe persistent hypertension.This review could not conclude about comparative effects due to insufficient data and suggested that further trials should compare Hydralazine with Nifedipine or labetalol, and to report severe persistent hypertension and adverse feto-maternal effects. OBJECTIVES:1) To compare efficacy and severe persistent hypertension after intravenous Labetalol versus Hydralazine, within maximum 5 drug boluses, in obstetric severe hypertensive patients at Civil Hospital Karachi. 2) To compare immediate adverse maternal and fetal effects in the study group. 3) Furthermore, to assess response to treatment, in terms of patient and disease characteristics. STUDY DESIGN: Randomized controlled trial. SETTING & DURATION OF STUDY: Gynaecology Unit I, Civil hospital Karachi, from Oct 2012 to Sep 2014 METHODS: Total one hundred eighty-four patients with, severe hypertension (systolic blood pressure(S.B.P)≥160 and/or diastolic blood pressure(D.B.P) ≥110 mm Hg) at greater than 28 weeks of pregnancy or upto 72 hours after delivery, were enrolled and randomly allocated to drug A or B. At enrollment, 94 patients were allocated to Labetalol to 96 to Hydralazine through simple randomization. Since six cases were excluded due to insufficient information( 2 from group A and 4 from group B) so finally data of 92 patients in each group was analyzed. Primary outcome measures were lowering of S.B.P to <160 mm Hg and D.B.P <110 mm Hg (efficacy)and severe persistent hypertension. In addition maternal hypo tension, tachycardia, bradycardia, adverse effect on fetal heart, still birth and neonatal bradycardia were measured. EXPECTED OUTCOME: Efficacy, severe persistent hypertension and side effects of Labetalol versus Hydralazine, in our population were determined. Assessment of response to Drug A and B, will help in choosing a drug for different patient and disease characteristics.
NCT02135315 ↗	Intensive Arterial Pressure Control in Acute Coronary Syndrome	Recruiting	Emergency NGO Onlus	N/A	2013-10-01	The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term. We compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.
NCT02135315 ↗	Intensive Arterial Pressure Control in Acute Coronary Syndrome	Recruiting	University of Monastir	N/A	2013-10-01	The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term. We compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.

Clinical Trial Conditions for Trandate Hct

Condition Name

Condition Name for Trandate Hct
Intervention	Trials
Pre-Eclampsia	2
Preeclampsia	2
Hypertension, Pregnancy-Induced	2

Condition MeSH

Condition MeSH for Trandate Hct
Intervention	Trials
Pre-Eclampsia	6
Hypertension	6
Hypertension, Pregnancy-Induced	4

Clinical Trial Locations for Trandate Hct

Trials by Country

Trials by Country for Trandate Hct
Location	Trials
United States	33
Tunisia	1
Egypt	1
Pakistan	1
Netherlands	1

Trials by US State

Trials by US State for Trandate Hct
Location	Trials
Tennessee	3
Ohio	2
Mississippi	1
Michigan	1
Louisiana	1

Clinical Trial Progress for Trandate Hct

Clinical Trial Phase

Clinical Trial Phase for Trandate Hct
Clinical Trial Phase	Trials
Phase 4	4
Phase 2	1
N/A	3

Clinical Trial Status

Clinical Trial Status for Trandate Hct
Clinical Trial Phase	Trials
Recruiting	2
Completed	2
Not yet recruiting	2

Clinical Trial Sponsors for Trandate Hct

Sponsor Name

Sponsor Name for Trandate Hct
Sponsor	Trials
McKay-Dee Hospital	1
University of South Alabama	1
Yale University	1

Sponsor Type

Sponsor Type for Trandate Hct
Sponsor	Trials
Other	79
NIH	1

Clinical Trials, Market Analysis, and Projections for Trandate (Labetalol Hydrochloride)

Introduction

Trandate, also known as labetalol hydrochloride, is a versatile antihypertensive medication that combines both alpha1-adrenergic and nonselective beta-adrenergic blocking activities. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy in Hypertension

Clinical trials have consistently shown that labetalol hydrochloride is effective in managing hypertension. A study comparing labetalol with hydrochlorothiazide (HCTZ) in elderly patients demonstrated that both drugs significantly reduced blood pressure, but labetalol offered some unique advantages, such as a lower rate of rise in diastolic blood pressure and mean arterial pressure during the acceleration period[1].

Safety and Tolerability

In controlled clinical trials, labetalol hydrochloride has been generally well-tolerated. Common adverse reactions include postural hypotension and/or dizziness (16.9%), fatigue/malaise (13.1%), and headache (8.0%)[5]. However, severe adverse reactions such as hepatotoxicity, myocardial infarction, and bronchospasm have been reported, although at a lower incidence[4].

Special Populations

Labetalol has been studied in various patient populations, including elderly patients and those with specific conditions like pheochromocytoma. In elderly patients, labetalol may require lower maintenance dosages compared to nonelderly patients[2]. For patients with pheochromocytoma, labetalol has been effective in lowering blood pressure and relieving symptoms, although caution is advised due to potential paradoxical hypertensive responses[2].

Market Analysis

Market Position

Trandate is a well-established drug in the antihypertensive market, with a strong presence in both the United States and other countries. Its unique dual-action mechanism sets it apart from other beta-blockers and alpha-blockers, making it a preferred choice for managing hypertension in various patient groups.

Competitors

The antihypertensive market is highly competitive, with numerous drugs available, including other beta-blockers, ACE inhibitors, ARBs, and calcium channel blockers. However, Trandate's dual-action profile and its efficacy in specific patient populations help it maintain a significant market share.

Pricing and Accessibility

The pricing of Trandate can vary depending on the region and the specific formulation (tablet or injection). Generally, it is considered a moderately priced antihypertensive drug, making it accessible to a wide range of patients. Generic versions of labetalol hydrochloride are also available, which can further reduce costs for patients.

Market Projections

Growth Potential

The global antihypertensive market is expected to grow due to increasing prevalence of hypertension, an aging population, and rising awareness about cardiovascular health. Trandate, with its proven efficacy and safety profile, is likely to benefit from this growth trend.

Emerging Markets

Emerging markets, particularly in Asia and Latin America, present significant growth opportunities for Trandate. These regions have large and growing populations with increasing rates of hypertension, and there is a growing demand for effective and affordable antihypertensive medications.

Innovations and Formulations

Continuous innovation in drug formulations and delivery systems could further enhance the market position of Trandate. For example, the development of extended-release formulations or combination therapies could improve patient compliance and outcomes.

Key Takeaways

• Efficacy: Trandate is effective in managing hypertension, with a unique dual-action mechanism that offers advantages over other antihypertensive drugs.
• Safety: While generally well-tolerated, Trandate can cause significant adverse reactions, and caution is advised in certain patient populations.
• Market Position: Trandate holds a strong position in the antihypertensive market due to its unique profile and efficacy.
• Growth Potential: The drug is expected to benefit from the growing global antihypertensive market, particularly in emerging regions.
• Innovations: Continuous innovation in formulations and delivery systems can further enhance its market position.

FAQs

Q: What is the primary mechanism of action of Trandate?

A: Trandate combines selective alpha1-adrenergic and nonselective beta-adrenergic blocking activities, making it effective in managing hypertension.

Q: What are the common adverse reactions associated with Trandate?

A: Common adverse reactions include postural hypotension and/or dizziness, fatigue/malaise, and headache. Severe reactions such as hepatotoxicity and myocardial infarction can also occur.

Q: Can Trandate be used in patients with pheochromocytoma?

A: Yes, but with caution. Labetalol has been shown to be effective in lowering blood pressure and relieving symptoms in patients with pheochromocytoma, although paradoxical hypertensive responses have been reported[2].

Q: Is Trandate safe for use during pregnancy?

A: Trandate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects such as hypotension, bradycardia, hypoglycemia, and respiratory depression have been reported in infants of mothers treated with labetalol during pregnancy[2].

Q: Are there any specific precautions for using Trandate in elderly patients?

A: Yes, elderly patients generally require lower maintenance dosages of Trandate compared to nonelderly patients. Regular monitoring of laboratory parameters is also recommended[2].

Sources

1. Comparison of labetalol and hydrochlorothiazide in elderly patients... - PubMed
2. Trandate (labetalol hydrochloride) tablet label - FDA
3. Labetalol hydrochloride tablets - FDA
4. Labetalol hydrochloride - Drug Summary - PDR
5. Labetalol Hydrochloride Tablets USP - Health Canada

Last updated: 2025-01-04