A Phase 3 interventional study of Ali/Amlo 150/2.5 mg in Essential Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 13 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 150 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Drug: Ali/Amlo 150/2.5 mg
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
Time frame: 52 weeks
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure.
Time frame: 52 weeks
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
Time frame: 52 weeks
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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