The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
910
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Diastolic Blood Pressure (msDBP)
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Daytime maSBP and maDBP
Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Nighttime maSBP and maDBP
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.
Time frame: Baseline and 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure
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Placebo was supplied as tablets in blister cards.
Novartis Investigative Site
Clearwater, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Metairie, Louisiana, United States
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Belzoni, Mississippi, United States
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Jackson, Mississippi, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Pulse rate measurements were performed. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Ambulatory Pulse Pressure
Pulse rate measurements were performed. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Dippers
Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Non-dippers
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.
Time frame: Baseline, 8 weeks
Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP \< 140/90 mmHg. Blood pressure response in msSBP was defined as \<140 mmHg or a reduction \>= 20mmHg from baseline. Blood pressure response in msDBP was defined as \< 90 mmHg or a reduction \>= 10 mmHg from baseline.
Time frame: 8 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Adverse event monitoring was conducted throughout the study.
Time frame: 8 weeks