Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)
1 other identifier
interventional
150
1 country
13
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 10, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 23, 2017
February 1, 2017
1.1 years
October 29, 2010
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.
52 weeks
Secondary Outcomes (2)
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.
52 weeks
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study
52 weeks
Study Arms (1)
Ali/Amlo
EXPERIMENTALAliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Interventions
Eligibility Criteria
You may qualify if:
- Patients that complete CSPA100A1301 study
- Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled
You may not qualify if:
- Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
- Presence of major protocol violation in CSPA100A1301 study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023, Japan
Novartis Investigative Site
Koshigaya, Saitama, 343-0826, Japan
Novartis Investigative Site
Edogawa-ku, Tokyo, 133-0061, Japan
Novartis Investigative Site
Katsushika-ku, Tokyo, 124-0024, Japan
Novartis Investigative Site
Kiyose, Tokyo, 204-0021, Japan
Novartis Investigative Site
Kunitachi, Tokyo, 186-0001, Japan
Novartis Investigative Site
Minato-ku, Tokyo, 105-7390, Japan
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075, Japan
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023, Japan
Novartis Investigative Site
Shibuya-ku, Tokyo, 150-0002, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032, Japan
Novartis Investigative Site
Tachikawa, Tokyo, 190-0013, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 10, 2010
Study Start
January 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 23, 2017
Record last verified: 2017-02