NCT00667719

A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren	300 mg tablet
DRUG	Amlodipine	5 mg tablet
DRUG	Hydrochlorothiazide	12.5 mg and 25 mg capsule

Timeline

• Start date: 2008-06-05
• Primary completion: 2009-10-05
• Completion: 2009-10-05
• First posted: 2008-04-28
• Last updated: 2021-06-07
• Results posted: 2021-06-07

Locations

8 sites across 8 countries: United States, Belgium, Egypt, Germany, Poland, Slovakia, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study