Approval Probability
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Label indication AVAPRO is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria.
Also known as IRBESARTAN (SR47436), Aprovel®
IRBESARTAN · 9 trials · 5 indications
The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.
| Arm | Type | Description |
|---|---|---|
| Irbesartan/Amlodipine 150/5 mg fixed combination | EXPERIMENTAL | 1 tablet once daily in the morning for 4 weeks Patient will be first treated with irbesartan 150mg or amlodipine 5mg, 1 tablet /day for 4 weeks. If OBPM is controlled on monotherapy at week 4 (SBP \<140 mmHg and DBP\<90 mmHg), patient will be withdrawn from the study |
| Irbesartan/Amlodipine 150/10 mg fixed combination | EXPERIMENTAL | 1 tablet once daily in the morning for 4 weeks |
| Irbesartan/Amlodipine 300/5 mg fixed combination | EXPERIMENTAL | 1 tablet once daily in the morning for 4 weeks |
| Irbesartan/Amlodipine 300/10 mg fixed combination | EXPERIMENTAL | 1 tablet once daily in the morning for 4 weeks. If OBPM is controlled at week 12, patients will continue on the same therapy until the end of the study |
| irbesartan/amlodipine | EXPERIMENTAL | Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 150/10 mg fixed combination for 5 additional weeks |
| amlodipine | ACTIVE_COMPARATOR | Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : amlodipine 5 mg for 5 weeks followed by amlodipine 10 mg for 5 additional weeks |
| irbesartan | ACTIVE_COMPARATOR | Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan 150 mg for 5 weeks followed by irbesartan 300 mg for 5 additional weeks |
| group verum | EXPERIMENTAL | Drug: Irbesartan |
| group placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Matching placebo up to final follow-up visit |
| Irbesartan 150mg | ACTIVE_COMPARATOR | Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg once a day. |
| Irbesartan 150 mg / Amlodipine 5 mg | ACTIVE_COMPARATOR | Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg / Amlodipine 5 mg once a day. |
| Irbesartan 300 mg | ACTIVE_COMPARATOR | Active Comparator: Irbesartan Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg once a day. |
| Irbesartan 300 mg / Amlodipine 5 mg | ACTIVE_COMPARATOR | Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg / Amlodipine 5 mg once a day. |
| Name | Type | Description |
|---|---|---|
| Irbesartan/Amlodipine (150/5mg) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Irbesartan/Amlodipine (150/10mg) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Irbesartan/Amlodipine (300/5mg) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Irbesartan/Amlodipine (300/10mg) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| irbesartan/amlodipine | DRUG | Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning |
| amlodipine | DRUG | Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning |
| irbesartan | DRUG | Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily |
| placebo | DRUG | one tablet per day during 2 years |
| Irbesartan/hydrochlorothiazide | DRUG | - |
| IRBESARTAN (SR47436) | DRUG | Oral administration of Irbesartan 150mg or 300mg once a day |
| Irbesartan / Amlodipine | DRUG | Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day |
Inclusion criteria : * Men and women ≥18 years old * Established essential hypertension * Treated with irbesartan 150 mg or amlodipine 5 mg as monotherapy for at least 2 weeks * With uncontrolled systolic BP (blood pressure) defined as ≥140 mm Hg assessed by OBPM (office blood pressure measurements...
Top 5 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 3 | PHASE3 | REGN7508, REGN9933 |
| Johnson & Johnson | JNJ | 14 | PHASE3 | Milvexian |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Abelacimab, PKN605 |
| Milestone Pharmaceuticals, Inc. | MIST | 1 | PHASE3 | Etripamil |
| Bayer | BAYRY | 1 | PHASE2 | BAY 3670549 |
Irbesartan is used to treat hypertension, or high blood pressure. It has also been studied in atrial fibrillation, chronic hepatitis C, and myocardial ischemia. It is a small molecule drug developed by Sanofi, and it is given both as a single agent and in fixed-dose combinations with amlodipine or hydrochlorothiazide.
Irbesartan targets AGTR1, the angiotensin II type 1 receptor, where it acts as an antagonist. By blocking this receptor, irbesartan interferes with angiotensin II signaling, which is a key pathway in blood pressure regulation. This mechanism underlies its use in hypertension and its investigation in other cardiovascular conditions.
Irbesartan is developed by Sanofi, which trades under the ticker SNY. Sanofi has run the clinical development program for irbesartan and its fixed-dose combinations, including irbesartan/amlodipine and irbesartan/hydrochlorothiazide, across multiple countries.
Irbesartan has been studied in Phase 3 clinical trials, including the fixed-dose combination program in hypertension. All six trials listed for irbesartan are completed, with no active trials currently ongoing. The completed studies enrolled a total of 9,016 participants.
Irbesartan has been evaluated in completed trials including NCT01625494, which tested irbesartan/amlodipine fixed combination therapy in hypertensive patients uncontrolled on monotherapy, and NCT00957554 and NCT00956644, which studied irbesartan/amlodipine in patients uncontrolled on irbesartan or amlodipine alone. NCT00950066 examined the irbesartan and amlodipine combination for blood pressure control.