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Last Updated: January 19, 2025

CLINICAL TRIALS PROFILE FOR MICARDIS


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All Clinical Trials for Micardis

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00034840 ↗ Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose Completed Bayer Phase 4 2001-10-01 The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗ Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose Completed GlaxoSmithKline Phase 4 2001-10-01 The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗ Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose Completed Boehringer Ingelheim Phase 4 2001-10-01 The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00133185 ↗ A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Completed Boehringer Ingelheim Phase 3 2004-03-01 The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Micardis

Condition Name

Condition Name for Micardis
Intervention Trials
Hypertension 53
Healthy 3
Diabetic Nephropathies 2
Metabolic Syndrome X 2
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Condition MeSH

Condition MeSH for Micardis
Intervention Trials
Hypertension 50
Essential Hypertension 6
Kidney Diseases 3
Metabolic Syndrome 2
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Clinical Trial Locations for Micardis

Trials by Country

Trials by Country for Micardis
Location Trials
United States 271
Canada 45
Korea, Republic of 9
Australia 7
France 6
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Trials by US State

Trials by US State for Micardis
Location Trials
California 12
Illinois 11
Texas 10
Georgia 10
Pennsylvania 9
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Clinical Trial Progress for Micardis

Clinical Trial Phase

Clinical Trial Phase for Micardis
Clinical Trial Phase Trials
Phase 4 18
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Micardis
Clinical Trial Phase Trials
Completed 61
Recruiting 7
Active, not recruiting 2
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Clinical Trial Sponsors for Micardis

Sponsor Name

Sponsor Name for Micardis
Sponsor Trials
Boehringer Ingelheim 52
Bayer 3
HK inno.N Corporation 2
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Sponsor Type

Sponsor Type for Micardis
Sponsor Trials
Industry 66
Other 33
NIH 1
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MICARDIS (Telmisartan): Clinical Trials, Market Analysis, and Projections

Introduction to MICARDIS (Telmisartan)

MICARDIS, known generically as telmisartan, is an angiotensin II receptor antagonist used primarily in the treatment of hypertension and diabetic nephropathy. It works by selectively blocking the binding of angiotensin II to the AT1 receptors, thereby lowering blood pressure and providing cardiac protection[5].

Clinical Trials and Safety Profile

ONTARGET Trial

One of the significant clinical trials involving telmisartan is the ONTARGET trial. This trial enrolled 25,620 patients aged 55 years or older with atherosclerotic disease or diabetes with end-organ damage. Patients were randomized to receive either telmisartan, ramipril, or the combination of both. The trial followed patients for a median of 56 months and found that while the combination of telmisartan and ramipril did not provide additional benefits compared to monotherapy, it did increase the incidence of renal dysfunction, including acute renal failure[1].

Adverse Events

Clinical trials have identified several adverse events associated with telmisartan. Common adverse events include upper respiratory tract infections, back pain, sinusitis, diarrhea, and pharyngitis. More serious adverse events, though rare, can include sepsis, thrombocytopenia, and acute renal failure. The discontinuation rate due to adverse events was 2.8% in patients treated with telmisartan compared to 6.1% in the placebo group[1][4].

Special Populations

The safety and efficacy of telmisartan have been evaluated in various patient populations, including the elderly. No significant differences in effectiveness and safety were observed between older and younger patients, although greater sensitivity in some older individuals cannot be ruled out[1].

Market Analysis

Current Market Size and Growth

The global telmisartan market is estimated to be valued at USD 4.20 billion in 2024 and is projected to reach USD 5.41 billion by 2031, exhibiting a compound annual growth rate (CAGR) of 3.7% from 2024 to 2031[2][5].

Market Drivers

Several factors are driving the growth of the telmisartan market:

  • Increasing Prevalence of Hypertension: With over 1.13 billion people globally affected by hypertension, the demand for effective antihypertensive therapies like telmisartan is high[2].
  • Rising Healthcare Spending: Growing healthcare expenditure, especially in emerging nations, is supporting the market growth.
  • Favorable Government Policies: Policies aimed at preventing and controlling hypertension also contribute to the market's expansion[2][5].

Market Segmentation

By Indication

The hypertension segment is expected to contribute the highest market share, estimated at 50.1% in 2024, due to the large patient pool and clinical need for effective blood pressure management[2].

By Dosage Form

The tablets segment is projected to dominate the market, contributing approximately 40.2% of the market share in 2024, driven by the presence of leading pharmaceutical companies and sophisticated healthcare infrastructure, particularly in North America[2].

Market Projections and Challenges

Future Growth Prospects

The telmisartan market is expected to continue growing due to factors such as:

  • Aging Population: The increasing senior population and sedentary lifestyle are significant drivers.
  • Clinical Demand: The ongoing need for effective and well-tolerated treatments for hypertension and related conditions[3][5].

Challenges

Despite the positive growth prospects, the market faces several challenges:

  • Generic Substitutes: The availability of generic substitutes once patents expire can hamper market growth.
  • Medication Shortages: Shortages of telmisartan can hinder market expansion.
  • Patent Expiration: The expiration of major brand patents can reduce market share for branded products[2][3].

Opportunities for Stakeholders

Expanding Therapeutic Applications

Continuous research on expanding the therapeutic applications of telmisartan beyond hypertension offers opportunities for stakeholders. Ongoing clinical trials evaluating its efficacy in treating other conditions can provide new avenues for growth[5].

Partnerships and Distribution

Partnerships with local distribution networks in developing countries can help leverage unmet demand and expand the market reach of telmisartan[5].

Key Takeaways

  • Clinical Trials: The ONTARGET trial highlighted the risks and benefits of combining telmisartan with other RAS inhibitors.
  • Market Size and Growth: The global telmisartan market is valued at USD 4.20 billion in 2024 and is expected to reach USD 5.41 billion by 2031.
  • Market Drivers: Increasing prevalence of hypertension, rising healthcare spending, and favorable government policies drive the market.
  • Challenges: Generic substitutes, medication shortages, and patent expirations pose challenges.
  • Opportunities: Expanding therapeutic applications and partnerships with local distribution networks offer growth opportunities.

FAQs

Q: What is the primary use of MICARDIS (telmisartan)?

A: MICARDIS (telmisartan) is primarily used for the treatment of hypertension and can also be used to reduce the risk of cardiovascular events in patients who cannot tolerate ACE inhibitors[5].

Q: What were the findings of the ONTARGET trial regarding telmisartan?

A: The ONTARGET trial found that combining telmisartan with ramipril did not provide additional benefits compared to monotherapy but increased the incidence of renal dysfunction[1].

Q: What are the common adverse events associated with telmisartan?

A: Common adverse events include upper respiratory tract infections, back pain, sinusitis, diarrhea, and pharyngitis. More serious events can include sepsis and acute renal failure[1][4].

Q: What is the projected market size of telmisartan by 2031?

A: The global telmisartan market is expected to reach USD 5.41 billion by 2031, growing at a CAGR of 3.7% from 2024 to 2031[2][5].

Q: What are the main challenges facing the telmisartan market?

A: The main challenges include the availability of generic substitutes, medication shortages, and the expiration of major brand patents[2][3].

Sources

  1. FDA Label for MICARDIS: Accessdata.fda.gov
  2. Telmisartan Market Report: Coherent Market Insights
  3. Telmisartan Market Size and Forecast: Straits Research
  4. Micardis Product Information: Boehringer Ingelheim
  5. Telmisartan Market by Composition, Indication, and Dosage Form: Global Industry Analysts Research Report

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