Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IRBESARTAN (SR47436)
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90 mmHg), patient will be withdrawn from the study |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...