Clinical trial NCT00171405: A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg
Official title: A 4 Month Extension to a 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long-term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
aliskiren
hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
2. absence of ongoing severe adverse events at Visit 10.

Primary outcomes:
measure: Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
Secondary outcomes:
measure: Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
measure: Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
measure: Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
measure: Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
measure: Blood pressure less than 140/90 mmHg
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Investigative Site
state: New Jersey
city: Deurne
country: Belgium
facility: Investigative Site
city: Ste-Fov
country: Canada
facility: Investigative Site
city: Krassel
country: Germany
facility: Investigative Site
city: Broni
country: Italy
facility: Investigative Site
city: Rotterdam
country: Netherlands
facility: Investigative Site
city: Lima
country: Peru
facility: Investigative Site
city: Moscow
country: Russian Federation
facility: Investigative Site
city: Basel
country: Switzerland
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.