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NCT00299806 Clinical Trial

SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00299806
Other study ID # CSPP100A1304
Secondary ID
Status Completed
Phase Phase 3
First received March 3, 2006
Last updated November 16, 2016
Start date April 2006
Est. completion date November 2006

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aliskiren

Locations
Country Name City State
Japan Novartis Pharmaceuticals Japan

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events after 8 weeks
Secondary Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks
Secondary 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
Secondary Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.
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