CLINICAL TRIALS PROFILE FOR CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE

All Clinical Trials for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01643434 ↗	Resistant Hypertension Optimal Treatment	Unknown status	Conselho Nacional de Desenvolvimento Científico e Tecnológico	Phase 4	2012-08-01	Resistant hypertension (ReHy) is an emerging clinical and public health problem which tends to increase because populations are living longer and there is a growing global epidemic of obesity, diabetes and sleep apnea. It is also tempting to speculate that the excessive dietary salt ingestion reported in many countries can contribute substantially to the risk of ReHy development. ReHy is defined as persistent high blood pressure (above the target goal) in spite of the use of at least 3 antihypertensive agents of different classes, one of them must being diuretics. Data regarding the exact prevalence of ReHy are very limited. In addition, little data is available about 3-drug combinations but a simplified treatment algorithm has demonstrated that a combination of a diuretic plus an angiotensin-converting enzyme inhibitors (ACEi) or an angiotensin-receptor blocker (ARB) plus diuretic, adding a calcium channel blocker when necessary, controlled 64% of hypertensive patients and, in addition, was even more efficient than the current guideline-based management. By contrast, the fourth drug to be added-on the triple regimen is still controversial and guided by empirical choices or personal preferences. Recent studies suggest the emerging role of spironolactone as the "first-line" fourth drug for treating resistant hypertension. Conversely, because of the pathophysiological rationale, others have proposed the use of β-blockers or even centrally acting agents for managing the sympathetic hyperactivity. The present concerns about the limited blood pressure reducing effect of β-blockers, especially in elderly people, the potent effect of centrally acting agents and our personal experience are pointing to clonidine as the fourth drug to be added-on to a multidrug combination for reaching optimal blood pressure in patients with ReHy. Nevertheless, no studies have been performed comparing, head-to-head, which one is the best fourth drug (spironolactone or clonidine) to be added-on to a common used multidrug combination in order to treat this condition. Therefore, the principal objectives of the ReHOT Trial are to assess prospectively: (1) the prevalence of ReHy in a cohort of outpatients with stage II hypertension; (2) the effect of spironolactone on blood pressure, in comparison to clonidine, when added to a multidrug combination consisting of chlorthalidone plus ACEi (or ARB) plus amlodipine, all of 3 up-titrated to the highest dose; (3) the role of measuring sympathetic nervous system activity and renin-angiotensin-aldosterone activity on predicting the response of blood pressure to spironolactone and clonidine.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

Clinical Trial Conditions for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE

Condition Name

Condition Name for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Intervention	Trials
Hypertension	2

Condition MeSH

Condition MeSH for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Intervention	Trials
Hypertension	2

Clinical Trial Locations for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE

Trials by Country

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Trials by Country for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Location	Trials
United States	10
Puerto Rico	1
Brazil	1

Trials by US State

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−

Trials by US State for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Location	Trials
Virginia	1
Tennessee	1
Pennsylvania	1
Ohio	1
Mississippi	1

Clinical Trial Progress for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE

Clinical Trial Phase

Clinical Trial Phase for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Clinical Trial Phase	Trials
Completed	1
Unknown status	1

Clinical Trial Sponsors for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE

Sponsor Name

Sponsor Name for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Sponsor	Trials
US Department of Veterans Affairs	1
VA Office of Research and Development	1
Conselho Nacional de Desenvolvimento Científico e Tecnológico	1

Sponsor Type

Sponsor Type for CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
Sponsor	Trials
U.S. Fed	2
Other	2

Clinical Trials, Market Analysis, and Projections for Clonidine Hydrochloride and Chlorthalidone

Introduction to Clonidine Hydrochloride and Chlorthalidone

Clonidine hydrochloride and chlorthalidone are two medications that play significant roles in managing hypertension and other cardiovascular conditions. Here, we will delve into recent clinical trials, market analysis, and projections for these drugs.

Clinical Trials: Clonidine Hydrochloride

Efficacy in Hypertension and ADHD

Clonidine hydrochloride, a centrally acting alpha-2 adrenergic agonist, has been extensively studied for its efficacy in managing hypertension and Attention Deficit Hyperactivity Disorder (ADHD). Clinical trials have shown that clonidine is effective in reducing blood pressure by activating brain receptors that decrease nerve impulses, thereby relaxing blood vessels[5].

Pediatric Use

In pediatric patients aged 6 to 17 years, clonidine has been proven effective in managing ADHD symptoms. Studies such as those involving Kapvay (clonidine extended-release) have demonstrated significant improvements in ADHD symptoms compared to placebo[3].

Safety and Adverse Effects

While clonidine is generally well-tolerated, it can have adverse effects such as hypotension, bradycardia, and cardiac conduction abnormalities. Clinical trials emphasize the need for careful titration and monitoring, especially in patients with pre-existing cardiac conditions[3].

Clinical Trials: Chlorthalidone

ALLHAT Trial

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a landmark study that compared chlorthalidone with doxazosin in high-risk hypertensive patients. The trial found that chlorthalidone was as effective as doxazosin in preventing coronary heart disease (CHD) and nonfatal myocardial infarction (MI) but significantly reduced the risk of combined cardiovascular disease (CVD) events, particularly congestive heart failure (CHF)[1].

Comparative Efficacy

Chlorthalidone was also compared to hydrochlorothiazide (HCTZ) in a VA clinical trial, which found that both drugs were equally effective in preventing cardiovascular disease and non-cancer death. This study highlighted the efficacy of chlorthalidone as a thiazide diuretic in managing hypertension[4].

Market Analysis: Clonidine Hydrochloride

Market Size and Growth

The clonidine hydrochloride market is growing due to the increasing prevalence of hypertension and the expanding therapeutic applications of the drug. The market size is projected to continue growing at a CAGR of 3.61%, driven by factors such as an aging population, rising healthcare expenditure, and improved access to medical care[2].

Therapeutic Applications

Clonidine hydrochloride is not only used for hypertension but also for managing ADHD, pain management, opioid withdrawal symptoms, and other conditions. This versatility broadens its market scope and increases demand[5].

Market Opportunities and Challenges

The market offers opportunities for innovation in drug delivery systems, such as extended-release formulations, which enhance patient compliance. However, challenges include potential side effects, stringent regulatory requirements, and competition from alternative therapies[2].

Market Analysis: Chlorthalidone

Market Stability

Chlorthalidone, as a well-established thiazide diuretic, maintains a stable market presence due to its proven efficacy in managing hypertension. The drug's performance in clinical trials, such as the ALLHAT study, reinforces its position in the antihypertensive market[1].

Competitive Landscape

Chlorthalidone competes with other thiazide diuretics like hydrochlorothiazide. The VA clinical trial indicating equal efficacy between chlorthalidone and HCTZ suggests a competitive but stable market environment[4].

Emerging Markets

Both clonidine hydrochloride and chlorthalidone have growth potential in emerging markets, particularly in regions with improving healthcare infrastructure. Localized pricing strategies and distribution networks can help expand their reach in these areas[5].

Projections for Clonidine Hydrochloride

Future Growth

The clonidine hydrochloride market is expected to grow significantly, driven by the increasing demand for hypertension management and the drug's expanding therapeutic applications. Innovations in drug delivery systems and the growing interest in non-opioid pain management solutions will further boost the market[2].

Geographic Expansion

Emerging markets in Asia-Pacific, Latin America, and Africa are expected to contribute substantially to the growth of the clonidine hydrochloride market. Companies focusing on these regions with tailored strategies can capitalize on the rising demand for effective and affordable treatments[5].

Projections for Chlorthalidone

Continued Use in Hypertension Management

Chlorthalidone is likely to remain a cornerstone in the management of hypertension due to its proven efficacy and safety profile. Its role in preventing CHF and other CVD events will continue to support its market presence[1].

Pragmatic Clinical Trials

The success of pragmatic trials like the VA study on chlorthalidone and HCTZ may lead to more such studies, further solidifying the drug's position in clinical practice without adding additional burden on patients[4].

Key Takeaways

• Clonidine Hydrochloride: Effective in hypertension and ADHD, with expanding applications in pain management and addiction treatment. The market is growing due to innovative drug delivery systems and increasing demand in emerging markets.
• Chlorthalidone: Proven efficacy in hypertension management, particularly in reducing CVD events. It remains a stable player in the antihypertensive market, with potential for continued use in pragmatic clinical trials.

FAQs

What are the primary uses of clonidine hydrochloride?

Clonidine hydrochloride is primarily used for managing hypertension and ADHD. It also has applications in pain management, opioid withdrawal symptoms, and other conditions.

How does chlorthalidone compare to other antihypertensive drugs?

Chlorthalidone has been shown to be as effective as doxazosin and hydrochlorothiazide in preventing CHD and nonfatal MI, but it significantly reduces the risk of combined CVD events, particularly CHF.

What are the market drivers for clonidine hydrochloride?

The market drivers include the increasing prevalence of hypertension, growing geriatric population, rising healthcare expenditure, and advancements in drug delivery systems.

What are the potential challenges for the clonidine hydrochloride market?

Challenges include potential side effects, stringent regulatory requirements, competition from alternative therapies, and fluctuating generic competition.

How is chlorthalidone expected to perform in the future market?

Chlorthalidone is expected to remain a key player in hypertension management due to its proven efficacy and safety profile, with continued use supported by pragmatic clinical trials.

Sources

1. ALLHAT Trial: "Major Cardiovascular Events in Hypertensive Patients Randomized to Doxazosin vs Chlorthalidone: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)" - JAMA[1].
2. Clonidine Market Report: "Clonidine Market Size, Competitors & Forecast to 2030" - Research and Markets[2].
3. Kapvay Monograph: "Clonidine Hydrochloride ER (Kapvay®)" - Texas Health and Human Services[3].
4. VA Clinical Trial: "VA’s New “burden-Free” Study Method Finds Two Blood Pressure Drugs Equally Effective" - VA Minneapolis Health Care[4].
5. Clonidine Hydrochloride Market: "Clonidine Hydrochloride Market Size And Projection" - Market Research Intellect[5].