SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

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. Identifier: NCT00299806
Recruitment Status : Completed
First Posted : March 7, 2006
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):

Brief Summary:
Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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
Study Start Date : April 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren

Primary Outcome Measures :
  1. Incidence of adverse events after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks
  2. 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
  3. Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00299806

Novartis Pharmaceuticals
Japan, Japan
Sponsors and Collaborators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals, Japan

Additional Information:
Responsible Party: Novartis Identifier: NCT00299806     History of Changes
Other Study ID Numbers: CSPP100A1304
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases