Trial Information

Summary: A Phase IIIB study to evaluate the efficacy of moderate (one drug) versus aggressive (two drugs) treatment for Stage 2 high blood pressure (Patient who has blood pressure readings between 160 and 185 mmHg (systolic), and between 100 and 109 mmHg (diastolic)).

Inclusion Criteria:

• Male or female patient, between 18-75 years of age.
• Patient must have a blood pressure reading between 160-185 mmHg (systolic, the higher of the two numbers of blood pressure measurements) and between 100-109 mmHg (diastolic, the lower of the two numbers of blood pressure measurements), on three repeated measurements. These readings are to be taken in seated position using an Omron electronic blood pressure measuring system at visit 1, prior to enrollment in the study.
• Patient must have the ability to communicate and comply with all the study requirements.
• All female patients of childbearing age must be practicing an effective non-hormonal method of birth control.

Exclusion Criteria:

• Patient’s high blood pressure is due to certain other diseases (secondary hypertension).
• Patient is on certain antihypertensive therapy within 3 months prior to enrollment in this study. However, certain medications used to treat heart attack or angina are allowed if they are started at least 3 months prior to start of this study.
• Patient has a history of heart attack, stroke, unstable angina, onset of heart failure, or has undergone certain heart procedures within the last 6 months, prior to visit 1.
• Patient has a history of hospitalization within the last month, prior to visit 1.
• Patient is a pregnant or lactating woman, or has a positive urine pregnancy test at visit 1.
• Patient has untreated/poorly treated diabetes mellitus as determined by HbA1c > 11% within one month prior to visit 1.
• Patient has impaired kidney and/or liver function.
• Patient is hypersensitive to the study drug(s).
• Patient has certain long-standing inflammatory conditions.
• Patient has enrolled in another study within 30 days of planned enrolment in this study.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.