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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR MICARDIS HCT


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All Clinical Trials for Micardis Hct

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 Hct

Condition Name

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

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

Trials by Country

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

Clinical Trial Phase

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

Sponsor Name

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

Sponsor Type for Micardis Hct
Sponsor Trials
Industry 66
Other 33
NIH 1
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MICARDIS HCT: Clinical Trials, Market Analysis, and Projections

Introduction

MICARDIS HCT, a combination of telmisartan and hydrochlorothiazide, is a widely used medication for the treatment of hypertension. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Mechanism of Action

MICARDIS HCT works by combining the effects of telmisartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic. Telmisartan inhibits the activity of angiotensin II, a chemical that constricts blood vessels, allowing blood to flow more freely and reducing blood pressure. Hydrochlorothiazide helps the body get rid of excess salt and water, further lowering blood pressure[4].

Clinical Trials Experience

Clinical trials have demonstrated the safety and efficacy of MICARDIS HCT. In controlled trials, MICARDIS HCT has been evaluated in over 1700 patients, with 716 patients treated for hypertension for more than 6 months and 420 for more than 1 year. Adverse reactions were generally limited to those previously reported with telmisartan and hydrochlorothiazide, with no unexpected adverse events observed[1].

Cardiovascular Outcomes

Studies have shown that telmisartan, a key component of MICARDIS HCT, exhibits superior efficacy in controlling 24-hour blood pressure compared to other ARBs. A meta-analysis indicated that telmisartan reduces visit-to-visit blood pressure variability and may reduce the risk of myocardial infarction in hypertensive patients[3].

Adverse Reactions and Safety Profile

Common Adverse Reactions

In clinical trials, adverse reactions occurring at an incidence of ≥2% in patients treated with MICARDIS HCT included dizziness, back pain, and upper respiratory tract infection. Increases in blood urea nitrogen (BUN) and serum creatinine were observed in a small percentage of patients, but no patient discontinued treatment due to these increases[1].

Postmarketing Experience

Postmarketing reports have included rare but serious adverse reactions such as eosinophilia, atrial fibrillation, and congestive heart failure. However, the frequency and causal relationship of these reactions to the drug are not always clear due to the voluntary nature of the reporting[1].

Market Analysis

Global Market Size and Growth

The global telmisartan market, which includes MICARDIS HCT, was valued at USD 3,567.30 million in 2023 and is projected to reach USD 4,661.27 million by 2032, growing at a CAGR of 3.4% during the forecast period. The telmisartan and hydrochlorothiazide drug market specifically is expected to reach USD 800.05 million by 2030[2][5].

Regional Market Dynamics

North America is expected to be the largest market for telmisartan, driven by the high prevalence of hypertension, advanced healthcare facilities, and a well-developed pharmaceutical infrastructure. The Asia-Pacific region, particularly countries like China and India, is expected to grow at a higher CAGR of 5.5% due to a large patient population and increasing healthcare expenditures[2].

Distribution Channels

Hospital pharmacies are a significant distribution channel for MICARDIS HCT, expected to generate USD 2,427.30 million by the end of the forecast period, growing at a CAGR of 3.5%. This segment's growth is driven by the increasing number of hypertension patients and improvements in hospital pharmacy structures in emerging economies[2].

Market Drivers and Challenges

Drivers

Key drivers of the telmisartan market include the increasing incidence of hypertension, an aging population, and a sedentary lifestyle. The approval of generic telmisartan tablets and the rise in chronic renal disease also contribute to market growth. Additionally, increasing awareness of hypertension and cardiovascular diseases fuels the demand for telmisartan medications[2].

Challenges

Despite the positive outlook, the market faces challenges such as medication shortages, which can hinder the expansion of the telmisartan market. However, ongoing research in emerging nations and the emphasis of top manufacturers on expanding their geographic presence are expected to create attractive opportunities during the forecast period[2].

Future Projections

Market Expansion

The telmisartan market is poised for significant growth, driven by the increasing demand for antihypertensive medications. The combination of telmisartan with other drugs, such as hydrochlorothiazide, is expected to remain a preferred treatment option for hypertension due to its efficacy and safety profile.

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, are expected to play a crucial role in the future growth of the telmisartan market. The large patient population and increasing healthcare expenditures in these regions present lucrative opportunities for market leaders.

Key Takeaways

  • Clinical Efficacy: MICARDIS HCT has been shown to be effective in controlling blood pressure and reducing cardiovascular risk.
  • Market Growth: The global telmisartan market is expected to grow at a CAGR of 3.4% from 2024 to 2032.
  • Regional Dynamics: North America and the Asia-Pacific region are key markets, with the latter expected to grow at a higher CAGR.
  • Distribution Channels: Hospital pharmacies are a significant distribution channel for MICARDIS HCT.
  • Market Drivers: Increasing incidence of hypertension, aging population, and rising awareness of cardiovascular diseases drive market growth.

FAQs

What is MICARDIS HCT used for?

MICARDIS HCT is used for the treatment of hypertension, alone or in combination with other antihypertensive agents, to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events[1].

What are the common adverse reactions associated with MICARDIS HCT?

Common adverse reactions include dizziness, back pain, and upper respiratory tract infection. Increases in BUN and serum creatinine can also occur, though rarely lead to treatment discontinuation[1].

How does telmisartan compare to other ARBs in terms of cardiovascular outcomes?

Telmisartan has been shown to have similar cardiovascular outcomes to other ARBs but with superior efficacy in controlling 24-hour blood pressure and reducing visit-to-visit blood pressure variability[3].

What are the key drivers of the telmisartan market?

Key drivers include the increasing incidence of hypertension, an aging population, sedentary lifestyle, approval of generic telmisartan tablets, and rising awareness of cardiovascular diseases[2].

Which regions are expected to drive the growth of the telmisartan market?

North America and the Asia-Pacific region are expected to be the primary drivers, with the Asia-Pacific region growing at a higher CAGR due to its large patient population and increasing healthcare expenditures[2].

Sources

  1. FDA Label: MICARDIS HCT tablets, for oral use. Initial U.S. Approval: 2000.
  2. Straits Research: Telmisartan Market Size, Share and Forecast to 2030.
  3. Oxford Academic: Three-Year Cardiovascular Outcomes of Telmisartan in Patients with Hypertension.
  4. FDA Label: Micardis® HCT Tablets, 40 mg/12.5 mg 80 mg/12.5 mg and 80 mg/25 mg.
  5. Verified Market Reports: Telmisartan and Hydrochlorothiazide Drug Market Size, Share, Trends.

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