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VALENCIA: Valturna Combinations in Hypertension and Diabetes
NCT01368536Phase 4
Key facts
- Status
- Terminated
- Start
- May 2011
- Primary completion
- Feb 2012
- Countries
- 2
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- hypertension (HTN)
01
Overview
Phase 4, randomised, double-blind trial of aliskiren + valsartan in hypertension (HTN) (3 arms), sponsored by Novartis. Primary endpoint: Mean Sitting Systolic Blood Pressure at 12 weeks. Started May 2011; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Valturna Alone
Valturna 150/160 mg + Placebo throughout
Valturna + Amlodipine
Valturna 150/160 mg + Amlodipine (titrated 5mg to 10mg)
Valturna + Chlorthalidone
Valturna 150/160 mg + Chlorthalidone (titrated 15mg to 25mg)
03
Who it enrols
Patients with stage 2 hypertension and type 2 diabetes mellitus (HbA1c <= 9%). Excludes patients on insulin or taking 4+ antihypertensives.
04
Endpoints
Primary
Mean Sitting Systolic Blood Pressure
Secondary
Mean Sitting Systolic Blood Pressure
Mean Sitting Diastolic Blood Pressure
Percentage of Responders
Percentage of Patients Achieving Blood Pressure Control
Adverse Events, Serious Adverse Events and Death
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