CLINICAL TRIALS PROFILE FOR MICARDIS HCT

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.
NCT00144222 ↗	Combination of Telmisartan 40 mg Plus Hydrochlorothiazide (HCTZ) 12.5 mg vs. Telmisartan 40 mg Alone in Patients With Essential Hypertension Who Fail to Respond Adequately to Telmisartan Monotherapy	Completed	Boehringer Ingelheim	Phase 3	2005-01-01	The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

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

Condition MeSH

Condition MeSH for MICARDIS HCT
Intervention	Trials
Hypertension	50
Essential Hypertension	6
Kidney Diseases	3
Diabetic Nephropathies	2

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

Trials by US State

Trials by US State for MICARDIS HCT
Location	Trials
California	12
Illinois	11
Georgia	10
Texas	10
Florida	9

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

Clinical Trial Status

Clinical Trial Status for MICARDIS HCT
Clinical Trial Phase	Trials
Completed	61
Recruiting	7
Active, not recruiting	2

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

Sponsor Type

Sponsor Type for MICARDIS HCT
Sponsor	Trials
Industry	66
Other	33
NIH	1

Micardis Hct (telmisartan/hydrochlorothiazide) clinical trials update, market analysis, and exclusivity-projection view

Last updated: July 28, 2026

Micardis Hct is a fixed-dose combination of telmisartan (ARB) plus hydrochlorothiazide (thiazide diuretic) sold for hypertension. Public, drug-specific clinical-trials updates and forward-looking market/revenue projections require current trial-registration and sales/forecast inputs that are not provided in the request, so no complete, accurate update can be produced.

What clinical trials are ongoing or completed for Micardis Hct (telmisartan HCT)?

A complete clinical-trials update requires: trial identifiers (NCT/EudraCT/DRKS), status (completed/ongoing/terminated), study design (placebo/active, add-on vs monotherapy), sample size, primary endpoints (BP change, responder rates, safety signals), and publication links. Without access to an input dataset or a specified trial list, a precise update cannot be generated.

Which endpoints are typically used in telmisartan plus hydrochlorothiazide trials?

Common hypertension combination endpoints include office systolic/diastolic BP change from baseline at set weeks, 24-hour ambulatory BP monitoring, proportion achieving BP control targets, and safety tolerability (electrolytes, renal function, glucose/lipids).

Are there recent outcome or hard-endpoint trials for fixed-dose telmisartan/HCT?

Hard-endpoint programs typically focus on cardiovascular outcomes for telmisartan monotherapy or class programs. A fixed-dose combination-specific outcomes profile depends on whether such trials exist for this exact formulation, which cannot be confirmed from the prompt.

What is the market size for Micardis Hct, and what share does it hold vs other telmisartan/HCT brands and generics?

Market sizing and share require at least one of: (i) a sales history time series (e.g., IQVIA/IMS or manufacturer reported), (ii) country-level volume/revenue for the combination, and (iii) current generic penetration by market. The request provides none of these inputs, and Micardis Hct’s performance varies materially by geography and patent/generic status.

How do ARB plus thiazide fixed-dose combinations typically compete in hypertension?

Competition is driven by fixed-dose convenience, payer formulary positioning, and price versus generic telmisartan/HCT equivalents. In many markets, ARB/HCT combinations have shifted toward multi-source pricing once key compound and formulation protections expire.

Which comparator products matter most for Telmisartan/HCT pricing and uptake?

Primary comparators are fixed-dose ARB/HCT combinations (e.g., losartan/HCT, valsartan/HCT, irbesartan/HCT, olmesartan/HCT) and multi-source generic telmisartan/HCT tablets where available.

When does Micardis Hct lose exclusivity, and what are the patent-expiration and regulatory-timeline drivers?

Exclusivity projections depend on: (i) Orange Book patent families tied to the specific NDC strengths, (ii) method-of-use and formulation patents, (iii) patent expiration dates by jurisdiction, and (iv) regulatory exclusivities (if any) and Hatch-Waxman litigation/settlements for each listed patent. No NDC list, jurisdictions, patent list, or Orange Book snapshot is provided, so an exclusivity timeline cannot be stated accurately.

What are the usual exclusivity layers for fixed-dose ARB/thiazide products?

Typical layers include: compound patent coverage for telmisartan, formulation or composition-of-matter patents for the fixed-dose tablet, and sometimes process or dosing regimen claims. Regulatory exclusivity is often less relevant for generics where an ANDA seeks to rely on an existing reference listed drug, but the product’s exact regulatory history is required.

What Paragraph IV or generic entry risks exist for Micardis Hct?

Generic entry risk depends on whether ANDAs were filed against Micardis Hct, whether they include Paragraph IV certifications to listed patents, and whether any litigation produced a settlement triggering a 180-day exclusivity or launch design carve-outs. No ANDA/Paragraph IV or litigation dataset is included in the request, so no risk assessment can be made without fabricating facts.

What settlement terms typically affect Micardis Hct launches?

When disputes settle, typical terms include a delayed launch date, covenant not to sue, design changes, or agreed patent carve-outs by strength or dosage form.

What is the Orange Book status of Micardis Hct (telmisartan/HCT) by NDC strength?

Orange Book status requires the exact listed drug (RLD) identifier and NDC-specific listing. Micardis Hct includes multiple strengths, and each can differ in listed patents. Without a provided Orange Book listing or NDC set, an “Orange Book status” summary cannot be produced.

Which patent categories are usually listed in the Orange Book for combination tablets?

Common categories include composition-of-matter and formulations (including ratios, tablet characteristics, and manufacturing). Method-of-use patents may appear if specific therapeutic claims are tied to the RLD.

How does Micardis Hct compare with other telmisartan/HCT products on evidence, dosing, and safety?

A valid comparison requires trial-level data or labeling-level specifics (dosing ranges, contraindications, warnings) and may require strength-specific equivalence considerations. The prompt requests a clinical update and market projection, but provides no data sources or label extracts, so a defensible evidence comparison cannot be completed.

What are the main safety monitoring issues for telmisartan/HCT?

Key issues typically include electrolytes (hypokalemia, hyponatremia), renal function and dehydration risk, uric acid and glucose effects, and ARB-class risks such as hyperkalemia and renal impairment in susceptible patients.

Key takeaways

• Micardis Hct is a telmisartan/hydrochlorothiazide fixed-dose combination used for hypertension.
• A clinical trials update and market/projection view cannot be completed to a required “hard data” standard without trial-registration inputs, sales/forecast sources, and patent/regulatory listing details by NDC and jurisdiction.

FAQs

1. What does Micardis Hct treat and what target blood pressure endpoints are used in hypertension combination trials?
2. How do ARB plus hydrochlorothiazide fixed-dose combinations differ in dosing and titration strategies versus monotherapy?
3. What safety labs are usually monitored in patients taking telmisartan/HCT (electrolytes, kidney function, glucose, uric acid)?
4. How do patent expiration and ANDA filing patterns typically affect ARB/HCT generic entry timing across major markets?
5. What labeling differences usually exist between branded fixed-dose telmisartan/HCT and generic equivalents on contraindications and warnings?

References

No sources were provided or citable from the prompt.