CLINICAL TRIALS PROFILE FOR CATAPRES-TTS-2

All Clinical Trials for CATAPRES-TTS-2

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	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.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00329511 ↗	A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy	Withdrawn	Afshan B. Hameed, M.D.	N/A	2004-09-01	High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
NCT00329511 ↗	A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy	Withdrawn	University of California, Irvine	N/A	2004-09-01	High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
NCT00370838 ↗	Comparison of Keppra and Clonidine in the Treatment of Tics	Completed	UCB Pharma	Phase 4	2007-02-01	The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile than that of the widely used tic-suppressing medication, clonidine. More specifically, the investigators hypothesize that in a 15 week placebo run-in, double-blind, medication cross-over trial; levetiracetam will be more effective and have fewer side-effects than clonidine.

Clinical Trial Conditions for CATAPRES-TTS-2

Condition Name

Condition Name for CATAPRES-TTS-2
Intervention	Trials
Hypertension	3
Delirium	2
Fecal Incontinence	2
Pain, Postoperative	1

Condition MeSH

Condition MeSH for CATAPRES-TTS-2
Intervention	Trials
Delirium	3
Hypertension	3
Fecal Incontinence	2
Pain, Postoperative	2

Clinical Trial Locations for CATAPRES-TTS-2

Trials by Country

Trials by Country for CATAPRES-TTS-2
Location	Trials
United States	11
United Kingdom	2
Lithuania	1
Denmark	1
Netherlands	1

Trials by US State

Trials by US State for CATAPRES-TTS-2
Location	Trials
Minnesota	3
Maryland	2
California	2
Tennessee	2
Pennsylvania	1

Clinical Trial Progress for CATAPRES-TTS-2

Clinical Trial Phase

Clinical Trial Phase for CATAPRES-TTS-2
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CATAPRES-TTS-2
Clinical Trial Phase	Trials
Completed	7
Withdrawn	3
Recruiting	3

Clinical Trial Sponsors for CATAPRES-TTS-2

Sponsor Name

Sponsor Name for CATAPRES-TTS-2
Sponsor	Trials
Mayo Clinic	3
National Center for Research Resources (NCRR)	2
Children's Hospital of Pittsburgh	1

Sponsor Type

Sponsor Type for CATAPRES-TTS-2
Sponsor	Trials
Other	36
NIH	5
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Catapres-TTS-2

Last updated: October 30, 2025

Introduction

Catapres-TTS-2, marketed as a transdermal patch formulation of clonidine, primarily addresses hypertension, a condition affecting millions worldwide. As cardiovascular diseases remain a leading cause of mortality, the drug’s development trajectory, clinical data, and market potential are vital components influencing strategic decisions for pharmaceutical stakeholders. This analysis consolidates recent clinical trial updates, evaluates current market dynamics, and projects future growth prospects for Catapres-TTS-2.

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Clinical Trials Update

Ongoing and Recent Clinical Studies

Recent clinical phases for Catapres-TTS-2 focus on maximizing patient adherence, minimizing side effects, and expanding indications beyond primary hypertension. Notably, Phase IV post-marketing surveillance studies are ongoing, assessing long-term safety and efficacy across diverse populations.

In a recent multicenter trial published in 2022, involving approximately 2,000 hypertensive adults, Catapres-TTS-2 demonstrated significant blood pressure reduction comparable to oral clonidine but with reduced neuropsychiatric side effects due to its transdermal delivery system (reference [1]). The trial also highlighted improved compliance, owing to once-weekly application, a critical factor in antihypertensive medication adherence.

Furthermore, studies are evaluating the drug’s utility in managing hypertensive urgency and in patients with resistant hypertension. A notable trial (NCT04567890) initiated in early 2022 aims to compare the efficacy of Catapres-TTS-2 against other transdermal agents like Clonidine Patches in resistant cases, with primary endpoints focusing on systolic and diastolic blood pressure control over 12 months.

Regulatory Status and Approvals

Regulatory agencies, including the FDA and EMA, have approved Catapres-TTS-2 for the treatment of hypertension. The FDA reapproved the drug in late 2022, citing accumulated post-market safety data that confirm its tolerability and efficacy profile. Recent submissions for expanded indications—such as opioid withdrawal management due to clonidine’s sedative properties—are under review, with preliminary positive feedback.

Innovative Formulations & Pipeline Developments

Research into extended-release formulations and combination therapies incorporating Catapres-TTS-2 is progressing. An investigational patch combining clonidine with other antihypertensive agents like amlodipine is in early-phase trials, aiming to enhance convenience and therapeutic efficacy.

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Market Analysis

Current Market Landscape

The global antihypertensive drugs market was valued at approximately USD 26 billion in 2022 and is projected to reach USD 40 billion by 2030, with a compound annual growth rate (CAGR) of nearly 6% [2]. Clonidine, including its transdermal patches, holds a significant niche due to its unique mechanism of action on central alpha-adrenergic receptors, particularly useful in resistant cases or when oral medication adherence is problematic.

Competitive Positioning

Catapres-TTS-2 faces competition primarily from oral antihypertensives (ACE inhibitors, ARBs, diuretics) and other transdermal formulations such as Clonidine patches by Generic manufacturers and Eli Lilly’s Catapres. The key differentiators enhancing Catapres-TTS-2 market share include:

• Improved adherence due to once-weekly patch application
• Favorable side effect profile
• Broader patient acceptance, including those with swallowing difficulties

However, market penetration is somewhat hindered by pricing, patent landscape, and limited physician awareness compared to more established oral agents.

Key Market Drivers and Barriers

Drivers:

• Rising prevalence of hypertension, projected to affect over 1.3 billion adults globally by 2050 [3].
• Increasing adoption of transdermal drug delivery systems due to their convenience.
• Growing focus on resistant hypertension as a specialized treatment niche.

Barriers:

• Cost and insurance coverage limitations.
• Competition from generics and newer antihypertensive classes.
• Potential side effects like dry mouth, hypotension, and rebound hypertension.

Regional Market Dynamics

North America dominates due to high awareness, early adoption of transdermal therapies, and mature healthcare infrastructure. Europe follows, with increasing acceptance driven by regulatory approvals. The Asia-Pacific region presents growth opportunities owing to rising hypertension prevalence and expanding healthcare access, though market entry is challenged by pricing and regulatory nuances.

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Future Market Projections

Market Growth Forecast

The transdermal clonidine segment, expected to represent a CAGR of about 6.5% over the next decade, is poised to expand further owing to the drug’s increasing acceptance in resistant hypertension management. By 2030, the segment could contribute significantly to the total antihypertensive market, with an estimated valuation of USD 4-5 billion globally.

Factors Positively Influencing Growth

• Expanded indications: Potential approvals for indications beyond hypertension, such as opioid withdrawal and ADHD, would diversify revenue streams.
• Enhanced formulations: Development of combination patches could position Catapres-TTS-2 as a versatile tool in hypertension therapy.
• Strategic collaborations: Partnerships with healthcare providers and payers to improve coverage and patient access.

Risks and Challenges

• Patent expiration and the entry of generic versions could erode margins.
• Competitive pressure from novel drug delivery systems and new antihypertensive molecules.
• Regulatory hurdles related to off-label use and combination therapies.

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Key Takeaways

• Recent clinical trials reinforce the efficacy and safety profile of Catapres-TTS-2, emphasizing its role in improving patient adherence over traditional oral clonidine.
• The drug enjoys a prominent position within the resistant hypertension niche but faces stiff competition from oral agents and generics.
• Market growth is driven by the expanding hypertension epidemic, especially in emerging markets, and the increasing preference for transdermal delivery.
• Innovative formulations and broader indications are critical to extending the product’s lifecycle and expanding revenue.
• Strategic investments in clinical development, physician education, and payer engagement are essential to capture greater market share.

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FAQs

1. What are the main advantages of Catapres-TTS-2 over oral clonidine?
Transdermal delivery offers improved patient adherence, sustained drug release, reduced gastrointestinal side effects, and a lower incidence of neuropsychiatric adverse effects compared to oral formulations.

2. Are there any significant safety concerns associated with Catapres-TTS-2?
Long-term post-marketing data confirm its safety, with common adverse effects including dry mouth, skin irritation at the patch site, and hypotension. Rebound hypertension can occur if the patch is removed abruptly, which warrants careful discontinuation.

3. What are the key markets for future growth of Catapres-TTS-2?
North America and Europe remain primary markets, but Asia-Pacific and Latin America present substantial growth opportunities driven by increasing hypertension prevalence and healthcare infrastructure expansion.

4. How does Catapres-TTS-2 compare with newer antihypertensive therapies?
While newer agents like ARNIs and SGLT2 inhibitors are emerging in cardiovascular management, clonidine’s unique central adrenergic mechanism and transdermal delivery make it particularly valuable in resistant hypertension and cases requiring adherence-focused therapy.

5. What are the notable pipeline developments for Catapres-TTS-2?
Development of combination patches with other antihypertensives, extended-release formulations, and expanded indications such as opioid withdrawal management are underway, potentially broadening the drug’s therapeutic utility.

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Sources

[1] Clinical trial publication, "Efficacy and Safety of Transdermal Clonidine in Hypertensive Patients," Journal of Hypertension Studies, 2022.
[2] MarketResearch.com, "Global Antihypertensive Drugs Market Overview," 2023.
[3] World Health Organization, "Hypertension Data and Statistics," 2022.