Back to resultsA Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
SPP100
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, angiotensin, renin, aliskiren
Eligibility Criteria
Inclusion Criteria: Diagnosed as essential hypertension - Exclusion Criteria: Patients with secondary hypertension or suspected of having secondary hypertension. Patients suspected of having malignant hypertension Patients with any serious diseases or symptoms
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
Secondary Outcome Measures
Change from baseline in diastolic blood pressure after 52 weeks
Change from baseline in systolic blood pressure after 52 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00246584
Brief Title
A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
Official Title
Long-Term Treatment, Multicenter, Open-Label Study With SPP100 in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, angiotensin, renin, aliskiren
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SPP100
Primary Outcome Measure Information:
Title
Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
Secondary Outcome Measure Information:
Title
Change from baseline in diastolic blood pressure after 52 weeks
Title
Change from baseline in systolic blood pressure after 52 weeks
Title
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as essential hypertension -
Exclusion Criteria:
Patients with secondary hypertension or suspected of having secondary hypertension.
Patients suspected of having malignant hypertension
Patients with any serious diseases or symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
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