SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00299832

First received: March 3, 2006

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2006

Last Updated Date

November 7, 2011

Start Date ^ICMJE

April 2006

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse events after 8 weeks

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00299832 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in mean sitting systolic blood pressure after 8 weeks
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Blood pressure <140/90 after 8 weeks

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Aliskiren

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00299832

Other Study ID Numbers ^ICMJE

CSPP100A1303

Has Data Monitoring Committee

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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