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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR ACETAZOLAMIDE SODIUM


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All Clinical Trials for Acetazolamide Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000115 ↗ Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema Completed National Eye Institute (NEI) Phase 2 1990-12-01 To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00962286 ↗ Effect of Furosemide on Obesity-induced Glomerular Hyperfiltration Terminated Rabin Medical Center N/A 2009-09-01 Background: Obesity is associated with a high prevalence of chronic kidney disease. The glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means may slow down the development and progression of chronic renal failure. The investigators have previously shown that acetazolamide, a proximally acting diuretic that activates TGF by increasing solute delivery to the macula densa, abates glomerular hyperfiltration. The present study was designed to test the hypothesis that this decrease in hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect. The aim of the present study is to evaluate the effects of the administration of furosemide p.o. to subjects with severe obesity on glomerular hemodynamics. Methods: Ten obese subjects will participate in the study. They will undergo measurement of glomerular filtration rate (inulin clearance) (GFR), renal plasma flow (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood pressure, before and after administration of oral furosemide 20 to 40 mg bid for 3 days. The effects of furosemide on glomerular hemodynamics in obese subjects will be compared to the previously studied effects of acetazolamide.
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed National Eye Institute (NEI) Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed University of California, Davis Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed University of Iowa Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed University of Rochester Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
NCT01003639 ↗ Idiopathic Intracranial Hypertension Treatment Trial Completed St. Luke's-Roosevelt Hospital Center Phase 2/Phase 3 2010-01-01 Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetazolamide Sodium

Condition Name

Condition Name for Acetazolamide Sodium
Intervention Trials
Idiopathic Intracranial Hypertension 2
Obesity-induced Hyperfiltration 2
Type 1 Diabetes 1
Acute Heart Failure 1
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Condition MeSH

Condition MeSH for Acetazolamide Sodium
Intervention Trials
Edema 2
Pseudotumor Cerebri 2
Intracranial Hypertension 2
Hypertension 2
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Clinical Trial Locations for Acetazolamide Sodium

Trials by Country

Trials by Country for Acetazolamide Sodium
Location Trials
United States 51
Canada 4
Israel 2
Puerto Rico 1
Italy 1
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Trials by US State

Trials by US State for Acetazolamide Sodium
Location Trials
California 3
Florida 2
Connecticut 2
Tennessee 2
Washington 2
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Clinical Trial Progress for Acetazolamide Sodium

Clinical Trial Phase

Clinical Trial Phase for Acetazolamide Sodium
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Acetazolamide Sodium
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 2
Terminated 2
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Clinical Trial Sponsors for Acetazolamide Sodium

Sponsor Name

Sponsor Name for Acetazolamide Sodium
Sponsor Trials
National Eye Institute (NEI) 3
Rabin Medical Center 2
University of Iowa 2
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Sponsor Type

Sponsor Type for Acetazolamide Sodium
Sponsor Trials
Other 18
NIH 3
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Acetazolamide Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Acetazolamide, a carbonic anhydrase inhibitor, has been a versatile medication used in various medical conditions, including glaucoma, altitude sickness, certain types of seizures, and recently, in the management of acute decompensated heart failure. This article delves into the recent clinical trials, market analysis, and future projections for acetazolamide sodium.

Clinical Trials: The ADVOR Trial

One of the most significant clinical trials involving acetazolamide is the Acetazolamide in Decompensated Heart Failure with Volume Overload (ADVOR) trial. This multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy of adding acetazolamide to standardized intravenous loop diuretics in patients with acute decompensated heart failure and volume overload.

Key Findings

  • The trial randomized 519 patients to receive either intravenous acetazolamide (500 mg/day) or a matching placebo, in addition to intravenous loop diuretics.
  • The primary outcome was complete decongestion within 3 days, which was achieved by 42.2% of patients in the acetazolamide group compared to 30.5% in the placebo group (p < 0.001)[3][4].
  • Acetazolamide also reduced the duration of hospital stay and improved diuretic response, measured by increased diuresis and natriuresis, and a more pronounced reduction in congestion scores[1][3].

Impact of Bicarbonate Levels

The ADVOR trial highlighted the importance of bicarbonate levels in the treatment response. Patients with elevated baseline or loop diuretic-induced bicarbonate levels showed a magnified treatment response to acetazolamide, as it counteracted the component of diuretic resistance associated with proximal nephron sodium and bicarbonate retention[1].

Market Analysis

Market Size and Forecast

The global acetazolamide market has shown significant growth and is projected to continue this trend. In 2022, the market size was valued at USD 263.04 billion and is expected to reach USD 499.69 billion by 2030, growing at a CAGR of 4.60% from 2023 to 2030[2].

Drivers of Growth

Several factors are driving the growth of the acetazolamide market:

  • Aging Population: An increasing aging population, particularly in regions like North America and Europe, contributes to higher demand for medications like acetazolamide[2][5].
  • Increased Diagnosis and Awareness: Growing awareness and diagnosis of conditions such as glaucoma and altitude sickness are boosting the demand for acetazolamide[2][5].
  • Expansion of Adventure and Travel Industries: The rise in adventure and travel activities at high altitudes increases the need for acetazolamide as a preventive measure for altitude sickness[2].
  • Generic Availability: The availability of acetazolamide as a generic medicine has made it more accessible and affordable, contributing to its market growth[5].

Regional Analysis

The global acetazolamide market is segmented into regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. North America, with its advanced healthcare infrastructure and large aging population, is a significant market. However, the Asia-Pacific region is the largest market due to the presence of several drug manufacturing companies and a large patient pool for various diseases[2][5].

Key Players

Major players in the acetazolamide market include Teva Pharmaceutical Industries Ltd., Mylan N.V., Sandoz International GmbH, Apotex Inc., Zydus Cadila, and others. These companies are involved in the production, distribution, and sales of acetazolamide and are driving innovation through new product launches and strategic collaborations[2][5].

Market Challenges and Opportunities

Challenges

  • Regulatory Compliance: The pharmaceutical industry is heavily regulated, and obtaining approvals for new formulations or indications can be a lengthy and complex process, posing challenges for manufacturers[2].
  • Alternative Medications: Competition from alternative drugs and therapies could impact the market share of acetazolamide[2].

Opportunities

  • Research and Development: Investing in research and development can lead to new formulations or expanded indications for acetazolamide, opening up new opportunities in the market[2].
  • Emerging Markets: Growing economies and increasing healthcare access in emerging markets offer untapped opportunities for acetazolamide manufacturers to expand their presence and cater to a broader patient base[2].

Future Projections

Market Growth

The acetazolamide market is expected to continue growing, driven by the increasing prevalence of medical conditions it treats, advancements in medical research, and the expanding availability of generic versions of the drug. The Asia-Pacific region is anticipated to remain the largest market due to its large patient pool and government support for providing basic medicines at low prices[2][5].

New Product Launches

Recent approvals, such as the final approval from the US FDA for Zydus Cadila's acetazolamide injection, are expected to boost the demand for acetazolamide in both developed and developing countries[5].

Key Takeaways

  • Clinical Efficacy: Acetazolamide has shown significant efficacy in improving decongestion in patients with acute decompensated heart failure when added to loop diuretics.
  • Market Growth: The global acetazolamide market is projected to grow at a CAGR of 4.60% from 2023 to 2030.
  • Regional Dominance: The Asia-Pacific region is the largest market for acetazolamide due to its large patient pool and government support.
  • Challenges and Opportunities: While regulatory compliance and competition from alternative medications pose challenges, research and development and emerging markets offer significant opportunities for growth.

FAQs

What is the primary use of acetazolamide in clinical settings?

Acetazolamide is primarily used to treat conditions such as glaucoma, altitude sickness, certain types of seizures, and recently, it has been used as an adjunct therapy in acute decompensated heart failure.

What were the key findings of the ADVOR trial?

The ADVOR trial found that adding acetazolamide to loop diuretics improved decongestion rates, reduced hospital stay duration, and enhanced diuretic response in patients with acute decompensated heart failure.

What is driving the growth of the acetazolamide market?

The growth of the acetazolamide market is driven by an aging population, increased diagnosis and awareness of treated conditions, expansion of adventure and travel industries, and the availability of generic versions of the drug.

Which region dominates the acetazolamide market?

The Asia-Pacific region is the largest market for acetazolamide due to the presence of several drug manufacturing companies and a large patient pool for various diseases.

What are the challenges faced by the acetazolamide market?

The market faces challenges such as regulatory compliance, competition from alternative medications, and potential side effects that may lead to the use of other alternatives.

Sources

  1. Academic.oup.com: Pre-treatment bicarbonate levels and decongestion by acetazolamide.
  2. Verified Market Research: Acetazolamide Market Size, Share, Trends, Analysis & Forecast.
  3. American College of Cardiology: Acetazolamide in Decompensated Heart Failure With Volume Overload.
  4. AHAJournals.org: Decongestion With Acetazolamide in Acute Decompensated Heart Failure Across the Spectrum of Left Ventricular Ejection Fraction.
  5. Infinium Global Research: Global Acetazolamide Market Size, Share, Trends, Analysis, Industry Report.

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