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Olmesartan medoxomil · 1 trial · 1 indication
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ | EXPERIMENTAL | During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. |
| Name | Type | Description |
|---|---|---|
| Amlodipine | DRUG | Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only. |
| Olmesartan medoxomil | DRUG | Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only. |
| Amlodipine+valsartan | DRUG | Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase. |
| Hydrochlorothiazide | DRUG | Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase. |
Inclusion Criteria for Core study: * Male or female patients (\>=18 years) * Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods * Patients with essential hypertension (diastolic blood pressure \>=100 mmHg and \<110 mmHg) Inclusion Crite...
Olmesartan medoxomil is used for hypertension, a condition of persistently high blood pressure. It is a small molecule being developed by Novartis AG for this cardiovascular indication. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for use.
Olmesartan medoxomil is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is intended for the treatment of hypertension and is currently in Phase 3 clinical trials.
Olmesartan medoxomil is in Phase 3 clinical development for hypertension. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for its efficacy and safety in adults with inadequately controlled hypertension.
Olmesartan medoxomil has one completed Phase 3 clinical trial registered under NCT00523744. The trial, titled 'Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension,' enrolled 257 participants in Germany. The study was not randomized, double-blind, or controlled, and it did not use biomarker selection.
Olmesartan medoxomil works by targeting the angiotensin II receptor, a key component in blood pressure regulation. By blocking this receptor, the drug helps relax blood vessels and lower blood pressure, which is beneficial for treating hypertension. This mechanism is typical of angiotensin receptor blockers.