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SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299832
First Posted: March 7, 2006
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299832


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

Additional Information:
Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00299832     History of Changes
Other Study ID Numbers: CSPP100A1303
First Submitted: March 3, 2006
First Posted: March 7, 2006
Last Update Posted: November 18, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Hypertension
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases