CLINICAL TRIALS PROFILE FOR ATENOLOL; CHLORTHALIDONE

All Clinical Trials for atenolol; chlorthalidone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000513 ↗	Trial of Antihypertensive Intervention Management	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-04-01	The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to determine the efficacy of dietary management and/or drug therapy, namely thiazide-like diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the effects of long-term weight reduction, and sodium/potassium changes added to weight reduction, as well as the original drug treatment, on the failure rate of blood pressure control.
NCT00000514 ↗	Systolic Hypertension in the Elderly Program (SHEP)	Completed	National Institute on Aging (NIA)	Phase 3	1984-06-01	The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.
NCT00000514 ↗	Systolic Hypertension in the Elderly Program (SHEP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-06-01	The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.
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.
NCT00408512 ↗	Pharmacosurveillance and Pharmacogenetics of First-line Diuretics in Hypertension: The StayOnDiur Study	Completed	Agenzia Italiana del Farmaco	Phase 4	2006-12-01	Background: The use of thiazide diuretics in the treatment of hypertension (HT) is widely considered a first line treatment, given the efficacy and low cost of this class of drugs. This indication is not unanimous, because thiazides can cause metabolic alterations and other side effects increasing cardiac and cerebrovascular risk, which reduce compliance to treatment and increase health care system cost. However, large intervention trials in HT suggest that the improvement in cardiovascular prognosis of HT patients depends more on follow-up procedures than on type of drug used. Furthermore, the investigators have documented improved compliance to antihypertensive therapy by implementing cooperation between general practitioners (GPs) and HT specialists. Objectives: In a multicenter, open label randomized study the investigators will compare the persistence on therapy of thiazides versus other treatments, as a first line antihypertensive therapy, in a clinical setting characterized by a strict cooperation between GPs and HT specialist. The investigators will also analyse candidate genes with impact on drug-induced metabolic alterations to elucidate the pathophysiology of these phenomena. Methods: 260 GPs will recruit 2600 hypertensive patients with indication to pharmacological treatment and randomise them to starting treatment with chlortalidone (12.5 to 25 mg daily, 1300 pts) or a GP decided single drug (excluding thiazides) or combination therapy at highest tolerated dose. In both groups any other class of antihypertensive drugs can be added over time in order to achieve blood pressure control (

Clinical Trial Conditions for atenolol; chlorthalidone

Condition Name

Condition Name for atenolol; chlorthalidone
Intervention	Trials
Hypertension	3
Heart Diseases	2
Cardiovascular Diseases	2
Vascular Diseases	1

Condition MeSH

Condition MeSH for atenolol; chlorthalidone
Intervention	Trials
Hypertension	3
Heart Diseases	2
Cardiovascular Diseases	2
Essential Hypertension	1

Clinical Trial Locations for atenolol; chlorthalidone

Trials by Country

Trials by Country for atenolol; chlorthalidone
Location	Trials
United States	10
Puerto Rico	1
Italy	1

Trials by US State

Trials by US State for atenolol; chlorthalidone
Location	Trials
Pennsylvania	1
Ohio	1
Mississippi	1
Iowa	1
Indiana	1

Clinical Trial Progress for atenolol; chlorthalidone

Clinical Trial Phase

Clinical Trial Phase for atenolol; chlorthalidone
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for atenolol; chlorthalidone
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for atenolol; chlorthalidone

Sponsor Name

Sponsor Name for atenolol; chlorthalidone
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
National Institute on Aging (NIA)	1
US Department of Veterans Affairs	1

Sponsor Type

Sponsor Type for atenolol; chlorthalidone
Sponsor	Trials
NIH	3
U.S. Fed	2
Other	2

Atenolol; chlorthalidone Market Analysis and Financial Projection

Last updated: April 29, 2026

Clinical Trials Update, Market Analysis and Projections: Atenolol + Chlorthalidone (Fixed-Dose Combination)

What is the drug and what trial activity matters commercially?

Atenolol plus chlorthalidone is a fixed-dose combination of a beta-1 selective blocker (atenolol) and a thiazide-like diuretic (chlorthalidone), positioned for hypertension treatment. Commercially relevant “trial activity” for an established, off-patent cardiovascular combination is usually driven by one of two paths:

1. New formulation or dosing regimens that can support differentiation and regulatory modernization.
2. Comparative effectiveness studies in hypertension populations (often with endpoints tied to blood pressure control and tolerability), typically run as post-authorization studies rather than pivotal efficacy registration programs.

No trial update can be produced to a “complete and accurate” standard from the information provided in this prompt. The request requires a current clinical-trials status (e.g., trial identifiers, enrollment, primary endpoints, results release dates, and geography), and those data are not present here.

What is the market context for atenolol + chlorthalidone?

Atenolol + chlorthalidone competes in a mature hypertension market dominated by:

• Generic beta-blockers (including atenolol) and diuretics (including thiazides and thiazide-like agents).
• Single-pill combinations (SPCs) from major classes such as ARB+thiazide, ACEi+thiazide, and CCB+ACEi/ARB.
• Lower cost generic combination therapy across many countries, which pressures pricing and reduces the revenue upside of marginal differentiation.

Key market drivers affecting projections:

• Guideline-directed first-line use of combinations for patients who do not achieve control on monotherapy.
• National formulary preferences that often favor specific SPCs with strong price and supply stability.
• Patent and regulatory status: for older generics, value tends to track volume, not innovation.

A complete market projection requires at least one of the following: current revenue/volume by geography, price trajectory, payer coverage, or market-share data. Those inputs are not included in the prompt, so a numerical forecast cannot be generated to the required standard.

What are the practical endpoints that trials would use for this combination?

When new studies are conducted in hypertension for this class of combination, typical endpoints include:

• Change from baseline in systolic and/or diastolic blood pressure at prespecified timepoints.
• Proportion achieving BP targets (often defined per protocol, sometimes aligned with guideline thresholds).
• Safety and tolerability focused on known class risks: electrolyte abnormalities (especially related to chlorthalidone), bradycardia or conduction effects (related to atenolol), renal function changes, and lab monitoring patterns.

A clinical-trial update that is “actionable for business decisions” also requires whether the new evidence changes prescribing patterns (e.g., shows superior adherence or fewer adverse events vs comparators). Without trial records or results text, this cannot be completed accurately.

How do you model market outlook without current sales data?

For established antihypertensive combinations, a robust projection model typically rests on:

• Addressable patient pool with uncontrolled hypertension in markets where the product is marketed.
• Share of combination therapy among treated hypertensive patients.
• Class and SPC mix (beta-blocker based vs ARB/ACEi+diuretic vs CCB-based SPCs).
• Generic competitive dynamics (number of entrants, margin compression, tender pricing).
• Regulatory and labeling (which determines whether the product is still preferred within formularies).

This modeling requires current market sizing inputs that are not in the prompt.

What can be said based on patent/protection reality?

Atenolol and chlorthalidone are older active ingredients; the fixed-dose combination is also widely available as generics in many jurisdictions. As a result, long-horizon value drivers generally come from:

• Availability and supply (stable manufacturing).
• Formulation-specific advantages (when supported by evidence).
• Local tender pricing and formulary inclusion.

A patent-by-patent protection map is required to determine exclusivity windows and risk of generic erosion. No such patent or regulatory dossier information is included here, so a protection-based commercial forecast cannot be produced to the required accuracy.

Projected commercial trajectory: what is the baseline shape for this category?

For mature generic antihypertensive combinations, the baseline trajectory is typically:

• Near-flat to declining net revenue over time as generic competition increases and pricing compresses.
• Volume sensitivity to guideline adherence, payer formularies, and primary-care prescribing habits.
• Limited upside unless a new differentiated product formulation or clinical evidence shift improves payer preference.

This is a qualitative pattern for the category, not a quantitative projection for the specific drug combination.

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Key Takeaways

• A current, actionable clinical trials update cannot be provided from the prompt because it lacks trial identifiers, status, endpoints, and result dates.
• A numerical market analysis and projection cannot be produced because it lacks required inputs on sales/volume, geography, pricing, and competitive landscape.
• Business-relevant drivers for atenolol + chlorthalidone are payer formularies, tender pricing, and generic competition dynamics, with value tied more to volume and supply stability than innovation.

FAQs

1. Is atenolol + chlorthalidone used as first-line therapy in hypertension?
   It is used clinically in hypertension management, often within combination therapy pathways, but exact first-line status depends on national guideline adoption and formulary rules.

2. What trial endpoints matter most for this combination?
   Change in systolic/diastolic BP, BP target attainment rates, and safety signals including electrolytes and bradycardia are the typical endpoints.

3. What drives revenue for mature generic hypertension combinations?
   Pricing through tender cycles, formulary inclusion, supply reliability, and total treated volume in hypertension.

4. How does generic competition affect projections?
   It typically compresses net pricing and margins over time, making volume and contracting terms the primary levers.

5. Can formulation-only changes materially improve market performance?
   They can, but only if they achieve meaningful differentiation via dosing convenience, tolerability, or evidence that shifts payer or prescriber behavior.

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References

[1] No sources were provided in the prompt, and no external data was retrieved.