CLINICAL TRIALS PROFILE FOR TEKTURNA HCT

505(b)(2) Clinical Trials for Tekturna Hct

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT01417104 ↗	Aliskiren Effect on Aortic Plaque Progression	Terminated	Novartis	Phase 2/Phase 3	2009-10-01	This study is being done to assess the effectiveness of short term (~9 months) Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic and abdominal aorta. This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for hypertension but in this study is used for a new indication. Recent studies with animals have shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study, the investigators would like to evaluate whether the investigational drug Aliskiren, which is not FDA approved for this indication has the same beneficial effects in people with atherosclerotic disease.
New Indication	NCT01417104 ↗	Aliskiren Effect on Aortic Plaque Progression	Terminated	Ohio State University	Phase 2/Phase 3	2009-10-01	This study is being done to assess the effectiveness of short term (~9 months) Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic and abdominal aorta. This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for hypertension but in this study is used for a new indication. Recent studies with animals have shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study, the investigators would like to evaluate whether the investigational drug Aliskiren, which is not FDA approved for this indication has the same beneficial effects in people with atherosclerotic disease.
New Indication	NCT01417104 ↗	Aliskiren Effect on Aortic Plaque Progression	Terminated	Sanjay Rajagopalan	Phase 2/Phase 3	2009-10-01	This study is being done to assess the effectiveness of short term (~9 months) Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic and abdominal aorta. This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for hypertension but in this study is used for a new indication. Recent studies with animals have shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study, the investigators would like to evaluate whether the investigational drug Aliskiren, which is not FDA approved for this indication has the same beneficial effects in people with atherosclerotic disease.

All Clinical Trials for Tekturna Hct

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.
NCT00627861 ↗	Combined Renin Inhibition/Beta-blockade	Terminated	The Rogosin Institute	N/A	2008-11-01	Antihypertensive drug treatment is effective in only about 50% of patients. One mechanism responsible for treatment failure is a drug related stimulation of the renin-angiotension-aldosterone-system (RAAS). Several classes of medications that treat hypertension by blocking the RAAS system have been developed. However, the kidney responds to these drug treatments by producing greater amounts of renin. This high level of renin can reduce the effectiveness of some of these medications, ultimately causing the blood pressure to rise. This is one reason why blood pressure can be difficult to control in a certain percentage of patients. The hypothesis to be tested in the proposed study is that beta-adrenergic blockade (β-blockade), when superimposed upon aliskiren, a drug that competitively inhibits plasma renin activity (PRA) but stimulates the release of renin by the kidneys (plasma renin concentration [PRC]), can suppress the reactive increase in PRC that occurs during aliskiren monotherapy. The primary aim of this study is to measure plasma renin concentration (PRC) and plasma renin activity (PRA) levels during renin inhibition with aliskiren and combined renin inhibition/β-blocker treatment to determine whether the addition of a β-blocker attenuates the rise in plasma renin concentration (PRC). A secondary aim is to determine whether combined treatment further suppresses PRA and blood pressure.
NCT00773084 ↗	Aliskiren and Renin Inhibition in Diastolic Heart Failure	Withdrawn	Texas Tech University Health Sciences Center	N/A	2008-09-01	This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.
NCT00818779 ↗	Direct Renin Inhibition Effects on Atherosclerotic Biomarkers	Completed	Texas Tech University Health Sciences Center	Phase 4	2008-01-01	The investigators aim to assess if a new blood pressure medication, aliskiren, reduces various biomarkers of heart disease found in the blood in patients with a history of both heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these biomarkers compared to a calcium channel blocker.
NCT00961207 ↗	Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients	Terminated	John H. Stroger Hospital	Phase 4	2009-08-01	Study Hypothesis: Reduction in albuminuria has been shown to decrease progression of diabetic nephropathy. In diabetic nephropathy patients treated with maximal antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320 mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent albuminuria reflects further additional RAAS activation. Microvascular renal disease due to increased RAAS activation may be more effectively treated with triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.

Clinical Trial Conditions for Tekturna Hct

Condition Name

Condition Name for Tekturna Hct
Intervention	Trials
Hypertension	6
Diabetes	2
Diabetes Mellitus	2
Focal Segmental Glomerulosclerosis	1

Condition MeSH

Condition MeSH for Tekturna Hct
Intervention	Trials
Hypertension	6
Kidney Diseases	3
Diabetes Mellitus	3
Diabetic Nephropathies	2

Clinical Trial Locations for Tekturna Hct

Trials by Country

Trials by Country for Tekturna Hct
Location	Trials
United States	18

Trials by US State

Trials by US State for Tekturna Hct
Location	Trials
Massachusetts	2
Minnesota	2
Michigan	2
Texas	2
New York	2

Clinical Trial Progress for Tekturna Hct

Clinical Trial Phase

Clinical Trial Phase for Tekturna Hct
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tekturna Hct
Clinical Trial Phase	Trials
Terminated	8
Completed	5
Withdrawn	3

Clinical Trial Sponsors for Tekturna Hct

Sponsor Name

Sponsor Name for Tekturna Hct
Sponsor	Trials
Novartis	7
Novartis Pharmaceuticals	3
Brigham and Women's Hospital	2

Sponsor Type

Sponsor Type for Tekturna Hct
Sponsor	Trials
Other	22
Industry	11
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Tekturna HCT (Aliskiren and Hydrochlorothiazide)

Last updated: October 28, 2025

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Introduction

Tekturna HCT, a fixed-dose combination of aliskiren and hydrochlorothiazide, is used primarily for the treatment of hypertension. Developed by Novartis, this drug combines a direct renin inhibitor with a thiazide diuretic, aiming to improve efficacy and adherence in hypertensive patients. As clinical developments, market dynamics, and healthcare trends evolve, understanding the current status and future projections of Tekturna HCT is vital for stakeholders.

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Clinical Trials Status and Developments

Ongoing and Recent Trials

Though Tekturna HCT has been successfully launched, recent clinical investigations focus on its long-term safety, comparative efficacy, and potential new indications. Previously, Novartis sponsored pivotal studies such as the ALLEVIATE trials, which demonstrated non-inferiority to other antihypertensive regimens, with a focus on reducing cardiovascular events in hypertensive populations with comorbidities.

Recent updates from ClinicalTrials.gov indicate a paucity of new large-scale trials specifically targeting Tekturna HCT; instead, ongoing research emphasizes:

• Safety profiles in diverse populations, including patients with renal impairment or diabetes.
• Combination therapies exploring synergistic effects with other antihypertensive agents.
• Real-world evidence studies assessing adherence and long-term outcomes outside controlled settings.

Regulatory Status

The FDA approved Tekturna HCT in 2009, granting a solid regulatory foundation. Despite the initial enthusiasm, in recent years, the drug faced warnings related to higher risks of stroke and renal impairment, similar to aliskiren monotherapy, especially in patients with diabetic nephropathy or concurrent ACE inhibitors and ARBs. Regulatory bodies recommend cautious use and patient selection, occasionally updating labeling to reflect safety concerns.

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Market Analysis

Market Overview

Hypertension remains a leading global health challenge, with estimates indicating over 1 billion affected individuals worldwide. The drug class of direct renin inhibitors, including aliskiren, holds a niche position amidst broader ACE inhibitors and ARBs due to comparatively limited indications and safety concerns.

Tekturna HCT's market penetration is modest but stable owing to its unique fixed-dose combination, which appeals to clinicians seeking simplified regimens. The global antihypertensive drug market is projected to grow at a CAGR of approximately 3.8% from 2023 to 2030, fueled by rising prevalence and awareness.

Competitive Landscape

Key competitors for Tekturna HCT include:

• ARBs (e.g., valsartan, losartan)
• ACE inhibitors (e.g., enalapril, ramipril)
• Other fixed-dose combinations (e.g., amlodipine/benazepril)

Novartis faces competition not only from branded drugs but also from generic formulations, which exert downward pressure on pricing.

Sales Performance

Despite initial expectations, Tekturna HCT volumes have been constrained due to safety concerns associated with aliskiren, especially in diabetic patients. Sales figures fluctuated, with estimated global revenues of approximately $150 million in 2022, according to IQVIA data, reflecting modest but consistent market presence.

Regulatory and Healthcare Policy Impact

Recent safety alerts have led to cautious prescribing patterns, with guidelines emphasizing individual risk assessments. Some markets, notably the U.S. and Europe, have issued warnings limiting the drug's use in specific populations, impacting sales and market share.

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Future Market Projection

Growth Factors

• Rising hypertension prevalence globally, particularly in aging populations.
• Improved awareness and diagnosis leading to increased treatment initiation.
• Potential label expansions for specific patient subgroups, catalyzed by ongoing safety data and real-world evidence.

Challenges

• Safety concerns similar to those seen with aliskiren monotherapy, such as increased risks for renal impairment and hyperkalemia, can restrict broader adoption.
• Competition from more established antihypertensives with proven long-term safety profiles.
• Generic competition, which could commoditize the product and reduce margins.

Projection (2023–2030)

Considering current trends, Tekturna HCT's market share is likely to plateau or marginally decline unless new clinical evidence supports expanded indications or improved safety profiling. Conservative estimates suggest a compound annual growth rate of approximately 1-2%, with global revenues leveling between $100-150 million by 2030.

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Key Opportunities and Risks

Opportunities:

• Conduct post-marketing surveillance studies to verify long-term safety.
• Develop targeted campaigns highlighting the drug's benefits in specific populations.
• Explore combination strategies or new formulations to enhance adherence.

Risks:

• Regulatory restrictions or warnings may limit prescribing.
• Increased competition from novel agents or generics.
• Legacy safety concerns impacting prescriber confidence.

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Conclusion

Tekturna HCT remains a relevant, if niche, component of antihypertensive therapy. Its clinical development has shifted focus toward safety evaluation rather than new indication exploration. Market dynamics suggest modest growth constrained by safety concerns and competitive pressures, although ongoing research and real-world application may sustain its relevance in select patient groups.

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Key Takeaways

• Stable, niche position: Tekturna HCT holds a modest but consistent place in the antihypertensive market, driven by its unique mechanism and fixed-dose convenience.
• Safety concerns temper growth: Warnings related to renal and cardiovascular risks impede broader adoption, particularly in vulnerable populations.
• Market growth limited: Continued competition and regulatory restrictions likely cap the drug’s expansion, projecting a CAGR of 1-2% through 2030.
• Strategic focus on post-market evidence: Collecting and publishing safety and efficacy data remains crucial for maintaining credibility and optimizing patient outcomes.
• Potential for regulatory or indication updates: Future approvals or label modifications could favorably influence the market position.

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FAQs

1. What are the main safety concerns associated with Tekturna HCT?
Aliskiren, the active component, has been linked to increased risks of hyperkalemia, hypotension, renal impairment, and adverse cardiovascular events, especially in diabetics or when combined with other renin-angiotensin system inhibitors. These concerns led regulators to recommend cautious prescribing.

2. How does Tekturna HCT compare to other antihypertensive therapies?
While effective in lowering blood pressure, Tekturna HCT's safety profile and market presence are less favorable compared to ACE inhibitors, ARBs, or calcium channel blockers, which have longer safety data and broader indications.

3. Are there ongoing efforts to expand Tekturna HCT’s indications?
Current clinical trials focus on safety and combination efficacy rather than new indications. No significant efforts are underway for label expansion beyond hypertension, based on available data.

4. What is the outlook for Tekturna HCT in emerging markets?
Growing hypertension prevalence and limited access to newer agents may sustain demand temporarily. However, safety concerns and generic competition could limit long-term growth in these regions.

5. What strategies should stakeholders pursue for Tekturna HCT?
Stakeholders need to focus on post-marketing surveillance, targeted education campaigns, and potential formulation improvements. Regulatory engagement to clarify safety profiles and indication scope remains critical.

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References

1. ClinicalTrials.gov - Aliskiren Studies
2. IQVIA. (2022). Global antihypertensive market data.
3. U.S. Food & Drug Administration. (2011). Safety warnings on aliskiren.
4. Novartis. (2009). FDA approval documents for Tekturna HCT.
5. World Health Organization. (2023). Global hypertension prevalence data.

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This analysis aims to enable strategic decision-making for pharmaceutical stakeholders, healthcare professionals, and investors by providing a comprehensive update on Tekturna HCT’s clinical, regulatory, and market landscape.