- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00299806
SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension
November 16, 2016 updated by: Novartis
A Multi-center, Open-label Study Assessing the Safety and Efficacy of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension
Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension
Study Overview
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Japan, Japan
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 20 - 80 years old
- Gender: Male or female
- Status: Outpatients
- severe hypertension
Exclusion Criteria:
- Patients with a clinically significant allergy
- Patients who have received other investigational drug
- Alcoholic patients
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of adverse events after 8 weeks
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks
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Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks
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Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals, Japan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
March 3, 2006
First Submitted That Met QC Criteria
March 3, 2006
First Posted (Estimate)
March 7, 2006
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSPP100A1304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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