Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olmesartan · 1 trial · 1 indication
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| LCZ696 | EXPERIMENTAL | Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd. |
| Olmesartan | ACTIVE_COMPARATOR | Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd. |
| Name | Type | Description |
|---|---|---|
| Olmesartan | DRUG | 10 mg, 20 mg, 40 mg capsules |
| Placebo | DRUG | Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule |
| LCZ696 | DRUG | 100 mg, 200 mg tablets |
Inclusion Criteria: * Patients must give written informed consent before any assessment is performed * Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and \< 180 mmHg * Patients must be able to ...
Olmesartan is used for essential hypertension, a form of high blood pressure. It belongs to the cardiovascular therapeutic area and is a small molecule drug. It has been studied in elderly patients aged 65 years and older with essential hypertension in a Phase 3 clinical trial.
Olmesartan targets AGTR1, the angiotensin II receptor type 1. It acts as an antagonist at this receptor, meaning it blocks the receptor's activity. This mechanism underlies its use in lowering blood pressure in patients with essential hypertension.
Olmesartan is developed by Novartis AG, which trades under the ticker NVS. The company sponsored the Phase 3 clinical trial evaluating the drug in elderly patients with essential hypertension across several Asian countries.
Olmesartan has been studied in Phase 3 clinical development for essential hypertension. The Phase 3 trial, NCT01615198, is completed. The drug is investigational in this development program and is not described as approved for this indication.
Olmesartan has been evaluated in the Phase 3 trial NCT01615198, titled Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension. The trial enrolled 588 patients, was randomized, double blind, and active controlled, and is completed.
The Phase 3 trial NCT01615198 compared LCZ696 with Olmesartan in elderly patients with essential hypertension. It enrolled 588 participants aged 65 years and older, across China, Hong Kong, Japan, the Philippines, South Korea, Taiwan, and Thailand. The trial was randomized, double blind, active controlled, and completed.