A Phase 4 interventional study of Aliskiren and HCTZ in High Blood Pressure, sponsored by Novartis. Completed at 7 sites in Venezuela. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Novartis · Phase 4, Interventional, and Treatment
This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (\< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.
6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.
This study's enrollment of 253 is above the median of 90 across 4,996 interventional studies indexed under Hypertension.
Browse Hypertension studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
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Exclusion Criteria:
aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg
Drug: Aliskiren and HCTZ
Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg
The proportion of patients in whom BP control was achieved at the study end point
Time frame: 16 weeks
The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point
Time frame: 8 weeks
Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.
Time frame: 16 weeks
Change in msSPA and msDBP from baseline to different time points
Time frame: 4,8,12 and 16 weeks
Safety of Aliskiren therapy at different time points
Time frame: 4,8,12 and 16 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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