This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
The patients were asked for 2 week run-in phase with atenolol 50 mg qd(once a day), followed by 4 schedule visits with 4-week interval until patient achieved BP goal. The maximum follow up was 16-week treatment. At visit 2, the patients started receiving Aliskiren/Amlodipine (150/5mg per day) for 4 weeks. At visit 3, if the patients did not achieve blood pressure (BP) goal, patients were up titrated to Aliskiren/Amlodipine (300/10 mg/day) for 4 weeks. At visit 4, if the patients did not achieve BP goal, HCT 12.5 mg/day was added to Aliskiren/Amlodipine/HCT (300/10/12.5 mg/day) for 4 weeks. Finally at visit 5, if the patients did not achieve BP goal, HCT was up titrated to Aliskiren/Amlodipine/HCT (300/10/25 mg/day) for 4 weeks until visit 6. Once the patients achieved BP goal at any visit, they completed the study.
Investigative Site
Bangkok, Thailand
Investigative Site
Chiang Mai, Thailand
Investigative Site
Nakhon Ratchasima, Thailand
Percentage of participants with stage II hypertension achieving blood pressure (BP) goal
The BP goal for non-diabetic patient is defined as msSBP \< 140 mmHg and msDBP \< 90 mmHg. The BP goal for diabetic patient is msSBP \< 130 mmHg and msDBP \< 80 mmHg) in patients with stage II hypertension.
Time frame: 18 weeks
Percentage of participants who have blood pressure surge to their baseline level during 24-h ambulatory blood pressure monitor (ABPM)
24-h ABPM profiles were assessed by percentage of participants who have blood pressure (BP) surge to their baseline level (during 24-h ABPM) once after patients achieve BP goal (BP goal for non-diabetic patient is defined as msSBP \< 140 mmHg and msDBP \< 90 mmHg; and the BP goal for diabetic patient is msSBP \< 130 mmHg and msDBP \< 80) at any visit only in selected study sites. The mean 24-hour MADBP (Mean Ambulatory Diastolic Blood Pressure) or MASBP (Mean Ambulatory Systolic Blood Pressure) is defined as the average of the hourly MADBP or MASBP over 24 hours respectively.
Time frame: 18 weeks
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to study end
mSBP and mDBP is defined as an average of 2 points blood pressure measurements which 5 minutes apart. Patient must be at rest for at least 5 minutes in sitting position before the heart rate and blood pressure measurement. The arm for blood pressure measurement should be the same during the whole study.
Time frame: From baseline to study completion (between week 8 to 18)
Number of participants with responder rate for Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
The responder rate of msSBP is defined as msSBP \< 140 mmHg for non-diabetic patients (msSBP \< 130 mmHg for diabetic patients) or by a reduction of ≥ 20 mmHg BP from baseline. The responder rate of msDBP is defined as msDBP \< 90 mmHg for non-diabetic patients ( msDBP \< 80 mmHg for diabetic patients) or by a reduction of ≥ 10 mm Hg BP from baseline
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Time frame: 18 weeks
Number of patients with any adverse events
An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the medicinal (investigational) product.
Time frame: 18 weeks