Essential Hypertension Clinical Trial
Official title:
Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone
Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven
to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This
study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive
patients whose blood pressure is not adequately controlled with OLM/AML alone. The following
treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg;
OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used
are as follows:
Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg
or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 -
Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM
40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg
n/a
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