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LCZ696 and Amlodipine in Essential Hypertension
NCT01865188Phase 3
Key facts
- Status
- Withdrawn
- Start
- Apr 2014
- Primary completion
- Apr 2015
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- essential hypertension
01
Overview
Phase 3, randomised, double-blind trial of sacubitril + valsartan in essential hypertension (9 arms), sponsored by Novartis. Primary endpoint: Mean Sitting Systolic Blood Pressure at 8 weeks. Planned start Apr 2014; status: withdrawn.
02
Design
9 arms- Study design
- RandomizedDouble-blind
LCZ696 200 mg
LCZ696 200 mg QD
LCZ696 400 mg
LCZ696 400 mg QD
Amlodipine 5 mg
Amlodipine 5 mg QD
Amlodipine 10 mg
Amlodipine 10 mg QD
LCZ 200 + Amlo 5
LCZ696 200 mg + Amlodipine 5 mg QD
LCZ 200 + Amlo 10
LCZ696 200 mg + Amlodipine 5 mg (1 wk) -> LCZ 200 + Amlo 10 (7 wks)
3 more in the full profile.
03
Who it enrols
Adult patients with mild-to-moderate essential hypertension (msSBP 150-180 mmHg). Excludes severe hypertension, secondary hypertension, recent stroke or MI, and history of angioedema.
04
Endpoints
Primary
Mean Sitting Systolic Blood Pressure
Secondary
Mean Sitting Diastolic Blood Pressure
Pulse Pressure
24-hour Ambulatory Systolic Blood Pressure
24-hour Ambulatory Diastolic Blood Pressure
Daytime Ambulatory Systolic Blood Pressure
Nighttime Ambulatory Systolic Blood Pressure
Trough to Peak Ratio of Ambulatory Blood Pressure
Blood Pressure Control Rate
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