SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00299806
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Apr 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	Japan		Japan

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals, Japan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00299806
• Other Study ID Numbers: CSPP100A1304
• First Posted: Mar 7, 2006
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Novartis: Hypertension, aliskiren, blood pressure, rennin
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Nov 18, 2016