Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00219037
- Lead Sponsor
- Novartis
- Brief Summary
Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1955
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adverse events, laboratory abnormalities, serious adverse events
- Secondary Outcome Measures
Name Time Method Change from baseline in mean sitting diastolic blood pressure after 12 months Change from baseline in mean sitting systolic blood pressure after 12 months Change from baseline in standing systolic blood and diastolic pressure after 12 months Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline Blood pressure less than 140/90 mmHg