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SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299806
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 and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

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 and Efficacy of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of adverse events after 8 weeks

Secondary Outcome Measures:
  • Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks
  • Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks
  • Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.

Enrollment: 39
Study Start Date: April 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (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
  • severe hypertension

Exclusion Criteria:

  • Patients with a clinically significant allergy
  • Patients who have received other investigational drug
  • Alcoholic patients

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): NCT00299806


Locations
Japan
Novartis Pharmaceuticals
Japan, Japan
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals, Japan
  More Information

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00299806     History of Changes
Other Study ID Numbers: CSPP100A1304
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
Vascular Diseases
Cardiovascular Diseases