CLINICAL TRIALS PROFILE FOR CHLORTHALIDONE

All Clinical Trials for Chlorthalidone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000499 ↗	Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)	Completed	National Institute on Aging (NIA)	Phase 2	1980-09-01	The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly. l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques. 2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens. 3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure. 4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population. 5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population. 6. To develop and test methods of ascertaining stroke and other disease endpoints.
NCT00000499 ↗	Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1980-09-01	The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly. l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques. 2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens. 3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure. 4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population. 5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population. 6. To develop and test methods of ascertaining stroke and other disease endpoints.
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.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	University of Minnesota	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.

Clinical Trial Conditions for Chlorthalidone

Condition Name

Condition Name for Chlorthalidone
Intervention	Trials
Hypertension	36
Essential Hypertension	8
Cardiovascular Diseases	7
Heart Diseases	7

Condition MeSH

Condition MeSH for Chlorthalidone
Intervention	Trials
Hypertension	51
Essential Hypertension	11
Cardiovascular Diseases	10
Heart Diseases	7

Clinical Trial Locations for Chlorthalidone

Trials by Country

Trials by Country for Chlorthalidone
Location	Trials
United States	249
Germany	16
Mexico	14
Korea, Republic of	13
Brazil	12

Trials by US State

Trials by US State for Chlorthalidone
Location	Trials
Florida	11
Texas	10
Virginia	10
Indiana	10
Alabama	9

Clinical Trial Progress for Chlorthalidone

Clinical Trial Phase

Clinical Trial Phase for Chlorthalidone
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	28
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Chlorthalidone
Clinical Trial Phase	Trials
Completed	39
Not yet recruiting	6
Withdrawn	6

Clinical Trial Sponsors for Chlorthalidone

Sponsor Name

Sponsor Name for Chlorthalidone
Sponsor	Trials
Takeda	9
National Heart, Lung, and Blood Institute (NHLBI)	8
Hospital de Clinicas de Porto Alegre	5

Sponsor Type

Sponsor Type for Chlorthalidone
Sponsor	Trials
Other	55
Industry	24
NIH	12

Chlorthalidone: Clinical Trials, Market Analysis, and Projections

Introduction to Chlorthalidone

Chlorthalidone is a thiazide-like diuretic commonly used in the management of hypertension and edema. It has been a staple in cardiovascular medicine for over five decades, known for its efficacy in lowering blood pressure and its long-lasting effects.

Clinical Trials: Comparing Chlorthalidone and Hydrochlorothiazide

Recent clinical trials have provided valuable insights into the comparative effectiveness of chlorthalidone and hydrochlorothiazide, another widely used thiazide diuretic.

Diuretic Comparison Project (DCP)

A prespecified secondary analysis of the Diuretic Comparison Project (DCP) revealed significant differences in outcomes between patients treated with chlorthalidone and those treated with hydrochlorothiazide. This study, published in JAMA Network Open, focused on patients with prior cardiovascular (CV) events such as myocardial infarction (MI) or stroke. The analysis showed that chlorthalidone was associated with a lower risk of secondary major adverse CV events (MACE) and noncancer-related deaths compared to hydrochlorothiazide. Specifically, chlorthalidone reduced the absolute risk of a second major CV event by 5.1% (95% CI, 4.0%-6.2%)[1].

VA Clinical Trial

A large VA clinical trial, which utilized a novel "burden-free" study method embedded in usual clinical care, found that chlorthalidone was not superior to hydrochlorothiazide for the prevention of cardiovascular disease or non-cancer death in the general population. This trial highlighted the real-world effectiveness of both medications without additional burden on the participants[3].

Kidney Outcomes

Another study examined the effects of chlorthalidone and hydrochlorothiazide on kidney outcomes. The results indicated that chlorthalidone was not superior to hydrochlorothiazide in preventing chronic kidney disease or acute kidney injury requiring hospitalization. However, chlorthalidone did cause slightly more hypokalemia (low potassium levels) compared to hydrochlorothiazide[4].

Adverse Effects and Considerations

Hypokalemia

Both studies mentioned above highlighted that chlorthalidone is associated with a higher prevalence of hypokalemia compared to hydrochlorothiazide. This is a significant consideration, as hypokalemia can increase the risk of cardiovascular events. However, the overall benefit of chlorthalidone in reducing CV events in certain patient subgroups may outweigh this risk[1][4].

Patient Subgroups

The DCP analysis emphasized the importance of patient subgroups, particularly those with prior MI or stroke. For these patients, chlorthalidone may offer additional benefits in reducing the risk of secondary CV events. This suggests that clinicians should consider the patient's medical history when choosing between chlorthalidone and hydrochlorothiazide[1].

Market Analysis and Projections

Global Market Growth

The global market for chlorthalidone API is expected to experience robust expansion. According to market research reports, the chlorthalidone API market is projected to grow at a significant compound annual growth rate (CAGR) over the next few years, reaching a substantial market size by 2024 and beyond[2][5].

Key Players and Market Segmentation

The market is dominated by several key players, including IPCA and Shreeji Pharma. The market segmentation includes analysis by manufacturers, regions (such as North America, Europe, Asia-Pacific, South America, Middle East, and Africa), type, and application. These reports provide detailed insights into the market competition landscape, SWOT analysis, and development plans of the key players[2][5].

Regional Analysis

The chlorthalidone API market is analyzed across various regions, with a focus on the competitive landscape and market share of key players in each region. This regional analysis helps in understanding the market dynamics and identifying opportunities for growth[2][5].

Market Drivers and Opportunities

Increasing Demand for Hypertension Treatment

The growing prevalence of hypertension globally drives the demand for effective antihypertensive medications like chlorthalidone. As the population ages and lifestyle factors contribute to higher blood pressure rates, the market for chlorthalidone is expected to expand[5].

Advancements in Manufacturing

Advancements in the manufacturing process and the development of new formulations are expected to enhance the market growth of chlorthalidone API. These improvements can lead to better product quality, reduced costs, and increased efficiency[5].

Market Restraints and Challenges

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulatory policies can impact the market for chlorthalidone API. Strict regulations and the need for continuous compliance can pose challenges for manufacturers[5].

Side Effects and Safety Concerns

The higher incidence of hypokalemia associated with chlorthalidone is a significant safety concern. This can affect patient compliance and may lead to a preference for alternative treatments, potentially impacting market growth[1][4].

Conclusion

Chlorthalidone remains a crucial medication in the management of hypertension, particularly for patients with prior cardiovascular events. Clinical trials have highlighted its benefits in reducing secondary CV events and noncancer-related deaths in these patient subgroups. The global market for chlorthalidone API is expected to grow significantly, driven by increasing demand for hypertension treatment and advancements in manufacturing. However, manufacturers must navigate regulatory challenges and address safety concerns related to hypokalemia.

Key Takeaways

• Chlorthalidone is associated with lower rates of major CV events and noncancer-related deaths in patients with prior MI or stroke compared to hydrochlorothiazide.
• The drug causes more hypokalemia than hydrochlorothiazide, which is a significant safety consideration.
• The global chlorthalidone API market is projected to grow at a significant CAGR over the next few years.
• Key players in the market include IPCA and Shreeji Pharma.
• Regulatory environment and safety concerns are key challenges for market growth.

FAQs

What are the main differences between chlorthalidone and hydrochlorothiazide in clinical trials?

Chlorthalidone has been shown to reduce the risk of secondary major adverse CV events and noncancer-related deaths more effectively than hydrochlorothiazide in patients with prior cardiovascular events. However, it causes more hypokalemia[1].

Which patient subgroups benefit most from chlorthalidone?

Patients with prior myocardial infarction (MI) or stroke benefit most from chlorthalidone, as it reduces the risk of secondary CV events in these subgroups[1].

What is the projected growth rate of the global chlorthalidone API market?

The global chlorthalidone API market is expected to grow at a significant compound annual growth rate (CAGR) over the next few years, reaching a substantial market size by 2024 and beyond[2][5].

Who are the key players in the chlorthalidone API market?

Key players in the market include IPCA and Shreeji Pharma, among others[2][5].

What are the main challenges facing the chlorthalidone API market?

The main challenges include regulatory environment changes, safety concerns related to hypokalemia, and the need for continuous compliance with regulatory policies[5].

Sources

1. AJMC: "Chlorthalidone May Be More Appropriate Diuretic for Patients With Hypertension, Previous CV Event" - June 12, 2024.
2. OpenPR: "Chlorthalidone API Market to Witness Robust Expansion by 2024" - No date specified.
3. VA.gov: "VA’s New “Burden-Free” Study Method Finds Two Blood Pressure Drugs Equally Effective" - December 14, 2022.
4. ACC.org: "Chlorthalidone vs. Hydrochlorothiazide and Kidney Outcomes" - December 20, 2024.
5. Cognitive Market Research: "Chlorthalidone API Market Report 2024 (Global Edition)" - No date specified.