This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
334
One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.
One tablet containing placebo, orally, once daily, for 8 weeks.
2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Time frame: Baseline and Week 8
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4
Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Time frame: Baseline and Week 4
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Time frame: Baseline and Week 8
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4
Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Time frame: Baseline and Week 4
Percentage of Participants Who Achieve Target Blood Pressure at Week 8
Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) \<90mmHg or sitting systolic BP (sitSBP) \<140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
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2 tablets containing placebo, orally, once daily, for 8 weeks.
Time frame: Week 8
Percentage of Participants Who Achieve Target Blood Pressure at Week 4
Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) \<90mmHg or sitting systolic BP (sitSBP) \<140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
Time frame: Week 4
Percentage of Participants Who Had Peripheral Edema During the Study
A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.
Time frame: up to 8 weeks
Change From Baseline in Ankle Circumference at Week 8
Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.
Time frame: Baseline and Week 8