This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
694
Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved.
The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - \<130 mm Hg; Diastolic - \<80 mm Hg.
Time frame: Baseline to ≤20 weeks
Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of \<140 mmHg and mean sitting diastolic blood pressure (dBP)of \<90 mmHg for non-diabetic patients or a mean sitting sBP at trough of \<130 mmHg and mean sitting dBP \<80 mmHg for diabetic patients.
Time frame: Baseline to ≤20 weeks
Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.
Time frame: Baseline to ≤20 weeks
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough
Time frame: Baseline to ≤20 weeks
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
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Unnamed facility
Fulpmes, Austria
University Klinik, F. Innere Medizin
Innsbruck, Austria
Unnamed facility
Innsbruck, Austria
Unnamed facility
Kundl, Austria
Unnamed facility
Salzburg, Austria
Diakonissen-Krankenhaus Hospital
Salzburg-Aigen, Austria
Unnamed facility
Brussels, Belgium
Unnamed facility
Mechelen, Belgium
Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care
Seraing, Belgium
Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan
Temse, Belgium
...and 69 more locations
Time frame: Baseline to ≤20 weeks
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Time frame: Baseline to ≤20 weeks