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NCT00299832 Clinical Trial

SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Hypertension Clinical Trial

Official title:
A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00299832
Other study ID # CSPP100A1303
Secondary ID
Status Completed
Phase Phase 3
First received March 3, 2006
Last updated November 16, 2016
Start date April 2006
Est. completion date May 2007

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, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2007
Est. primary completion date May 2007
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

- Elevated Serum Creatinine

Exclusion Criteria:

- Patients suspected of malignant hypertension

- Patients with a clinically significant allergy

- Patients who have received other investigational drug 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, 

References & Publications (1)

Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res. 2010 Jan;33(1):62-6. doi: 10.1038/hr.2009.175. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events after 8 weeks
Secondary Change from baseline in mean sitting systolic blood pressure after 8 weeks
Secondary Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Secondary Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
Secondary Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Secondary Blood pressure <140/90 after 8 weeks
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