Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Axthelm, Dr. med., Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: +41-61-324-1111
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.
Clinical Details
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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in mean sitting diastolic blood pressure after 4 weeks of treatment
Secondary outcome: 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/HCTChange 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, Phone: +41-61-324-1111
Investigative Site, Pirna, Germany; Recruiting
Novartis, Phone: 41 61 324 1111
Additional Information
Starting date: May 2010
Last updated: May 20, 2010
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