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drugset / Trial / NCT00171405

A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

NCT00171405 ↗

Phase 3 Completed 250 enrolled Novartis

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.

Timeline

Start: 2005-06
Primary completion: 2006-02
Completion: 2006-02

Publications

Results Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aliskiren	Small molecule	150 mg	Oral
Subject	Aliskiren	Small molecule	300 mg	Oral

Indications