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

March 3, 2006
November 7, 2011
April 2006
May 2007   (final data collection date for primary outcome measure)
Adverse events after 8 weeks
Not Provided
Complete list of historical versions of study NCT00299832 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
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

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: Aliskiren
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00299832
CSPP100A1303
No
Novartis
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
November 2011

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