Back to resultsAliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine (AWESOME)
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Hypertension, Aliskiren, Amlodipine
Eligibility Criteria
Inclusion Criteria:
- Essential hypertension stage II
- Male and female patients
- Age >= 18 years old
Exclusion Criteria:
- Severe hypertension (systolic BP >= 180 mmHg, diastolic BP >= 110 mmHg
- Poorly controlled diabetes mellitus or type 1 DM
- History of myocardial infarction, stroke
- Presence of heart failure
- Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non responder Olmesartan/Amlodipine
Arm Description
Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
Outcomes
Primary Outcome Measures
Change in mean sitting diastolic blood pressure after 4 weeks of treatment
Secondary Outcome Measures
Change in mean sitting systolic blood pressure reduction after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
Change in heart rate, pulse pressure, responder rates, normalization rates after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01113047
Brief Title
Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine
Acronym
AWESOME
Official Title
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Single Pill (SPC) Combination of Aliskiren 300 mg / Amlodipine 10 mg in Hypertensive Patients Not Adequately Respond to an Uptitrated 4 Week Therapy With the SPC of Olmesartan 40 mg / Amlodipine 10 mg, With a Potential Extension if Patients Still Not Adequately Respond With a 4 Week Therapy With the SPC Aliskiren 300 mg / Amlodipine 10 mg / HCTZ 12,5 mg
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.
Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Hypertension, Aliskiren, Amlodipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non responder Olmesartan/Amlodipine
Arm Type
Experimental
Arm Description
Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
Intervention Type
Drug
Intervention Name(s)
Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
Intervention Description
Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg
Primary Outcome Measure Information:
Title
Change in mean sitting diastolic blood pressure after 4 weeks of treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in mean sitting systolic blood pressure reduction after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
Time Frame
4 weeks
Title
Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
Time Frame
4 weeks
Title
Change in heart rate, pulse pressure, responder rates, normalization rates after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Essential hypertension stage II
Male and female patients
Age >= 18 years old
Exclusion Criteria:
Severe hypertension (systolic BP >= 180 mmHg, diastolic BP >= 110 mmHg
Poorly controlled diabetes mellitus or type 1 DM
History of myocardial infarction, stroke
Presence of heart failure
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axthelm, Dr. med.
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Pirna
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27536431
Citation
Axthelm C, Sieder C, Meister F, Pittrow D, Kaiser E. Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index. J Drug Assess. 2012 Dec 25;2(1):1-10. doi: 10.3109/21556660.2012.762367. eCollection 2013.
Results Reference
derived
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Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine
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