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
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Aliskiren
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse events after 8 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 40
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299832

Locations
Japan
Novartis Pharmaceuticals
Japan, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00299832     History of Changes
Other Study ID Numbers: CSPP100A1303
Study First Received: March 3, 2006
Last Updated: November 7, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, rennin

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014