A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg
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
1 other identifier
interventional
250
10 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Jun 2005
Shorter than P25 for phase_3 hypertension
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedNovember 18, 2016
November 1, 2016
8 months
August 24, 2005
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
Secondary Outcomes (5)
Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
Blood pressure less than 140/90 mmHg
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- absence of ongoing severe adverse events at Visit 10.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (10)
Investigative Site
East Hanover, New Jersey, United States
Investigative Site
Deurne, Belgium
Investigative Site
Ste-Fov, Canada
Investigative Site
Krassel, Germany
Investigative Site
Broni, Italy
Investigative Site
Rotterdam, Netherlands
Investigative Site
Lima, Peru
Investigative Site
Moscow, Russia
Investigative Site
Basel, Switzerland
Investigative Site
London, United Kingdom
Related Publications (1)
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.
PMID: 22035463RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 24, 2005
First Posted
September 15, 2005
Study Start
June 1, 2005
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11