At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 601 enrolled
Drug / intervention
Aliskiren +2 moredrug
Likely dose
Aliskiren 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)
In Brief
A Phase 3 clinical trial evaluating Aliskiren, Valsartan, and 1 other intervention for Hypertension. Completed, enrolled 601 participants across 4 sites in 4 countries.
Detailed Summary
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesCanada, Germany, Netherlands, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedOct 2006
Primary CompletionJul 2008
TodayJul 2026
First PostedOct 11, 2006
Enrollment StartOct 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.7 years ago
Interventions
Aliskirendrug
Aliskiren 300 mg
Valsartandrug
Valsartan 320 mg
Hydrochlorothiazide (HCTZ)drug
Hydrochlorothiazide (HCTZ) 12.5-25 mg