Back to resultsLong Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
aliskiren
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, blood pressure, aliskiren
Eligibility Criteria
Inclusion Criteria Patients with essential hypertension. Patients who are eligible and able to participate in the study. Exclusion Criteria Severe hypertension. History or evidence of a secondary form of hypertension. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Adverse events, laboratory abnormalities, serious adverse events
Secondary Outcome Measures
Change from baseline in mean sitting diastolic blood pressure after 12 months
Change from baseline in mean sitting systolic blood pressure after 12 months
Change from baseline in standing systolic blood and diastolic pressure after 12 months
Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline
Blood pressure less than 140/90 mmHg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00219037
Brief Title
Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension
Official Title
A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, blood pressure, aliskiren
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
1955 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aliskiren
Primary Outcome Measure Information:
Title
Adverse events, laboratory abnormalities, serious adverse events
Secondary Outcome Measure Information:
Title
Change from baseline in mean sitting diastolic blood pressure after 12 months
Title
Change from baseline in mean sitting systolic blood pressure after 12 months
Title
Change from baseline in standing systolic blood and diastolic pressure after 12 months
Title
Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline
Title
Blood pressure less than 140/90 mmHg
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients with essential hypertension.
Patients who are eligible and able to participate in the study.
Exclusion Criteria
Severe hypertension.
History or evidence of a secondary form of hypertension.
History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Investigative Sites
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22035463
Citation
Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.
Results Reference
derived
Learn more about this trial
Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension
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