Back to resultsClinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
aliskiren
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, aliskiren, blood pressure, hydrochlorothiazide (HCTZ).
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
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Change from baseline in diastolic blood pressure after 8 weeks
Secondary Outcome Measures
Change from baseline in systolic blood pressure after 8 weeks
Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks
Blood pressure < 140/90 mmHg
Change from baseline in standing diastolic blood pressure after 8 weeks
Change from baseline in standing systolic blood pressure after 8 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00219024
Brief Title
Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.
Official Title
An 8 Week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, aliskiren, blood pressure, hydrochlorothiazide (HCTZ).
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2775 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aliskiren
Primary Outcome Measure Information:
Title
Change from baseline in diastolic blood pressure after 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in systolic blood pressure after 8 weeks
Title
Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks
Title
Blood pressure < 140/90 mmHg
Title
Change from baseline in standing diastolic blood pressure after 8 weeks
Title
Change from baseline in standing systolic blood pressure after 8 weeks
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:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
Country
United States
City
Investigative Centers
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21659626
Citation
Yan JH, Jarugula V, Sabo R, Papst CC, Zhang J, Dole WP. Pharmacokinetics and pharmacodynamics of aliskiren/hydrochlorothiazide single-pill combination tablets and free combination of aliskiren and hydrochlorothiazide. J Clin Pharmacol. 2012 May;52(5):645-55. doi: 10.1177/0091270011405499. Epub 2011 Jun 9.
Results Reference
derived
Learn more about this trial
Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.
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