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Last Updated: December 12, 2024

CLINICAL TRIALS PROFILE FOR TELMISARTAN


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505(b)(2) Clinical Trials for Telmisartan

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT02262572 ↗ Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects Completed Boehringer Ingelheim Phase 1 2003-04-01 Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Telmisartan

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.
NCT00067977 ↗ HALT Progression of Polycystic Kidney Disease Study B Completed Boehringer Ingelheim Phase 3 2006-01-01 The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
NCT00067977 ↗ HALT Progression of Polycystic Kidney Disease Study B Completed Merck Sharp & Dohme Corp. Phase 3 2006-01-01 The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Telmisartan

Condition Name

Condition Name for Telmisartan
Intervention Trials
Hypertension 155
Healthy 40
Essential Hypertension 10
Hyperlipidemia 9
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Condition MeSH

Condition MeSH for Telmisartan
Intervention Trials
Hypertension 145
Essential Hypertension 23
Diabetes Mellitus 11
Hyperlipidemias 11
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Clinical Trial Locations for Telmisartan

Trials by Country

Trials by Country for Telmisartan
Location Trials
United States 394
Korea, Republic of 95
Canada 77
Australia 26
Spain 23
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Trials by US State

Trials by US State for Telmisartan
Location Trials
California 19
Georgia 16
Florida 16
Ohio 15
Texas 15
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Clinical Trial Progress for Telmisartan

Clinical Trial Phase

Clinical Trial Phase for Telmisartan
Clinical Trial Phase Trials
Phase 4 70
Phase 3 66
Phase 2/Phase 3 3
[disabled in preview] 86
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Clinical Trial Status

Clinical Trial Status for Telmisartan
Clinical Trial Phase Trials
Completed 219
Recruiting 18
Unknown status 16
[disabled in preview] 14
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Clinical Trial Sponsors for Telmisartan

Sponsor Name

Sponsor Name for Telmisartan
Sponsor Trials
Boehringer Ingelheim 134
Chong Kun Dang Pharmaceutical 18
Yuhan Corporation 12
[disabled in preview] 18
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Sponsor Type

Sponsor Type for Telmisartan
Sponsor Trials
Industry 217
Other 134
NIH 9
[disabled in preview] 1
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