NCT00778921CompletedPhase 3
A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 847
- Locations
- 1
- Primary Endpoint
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Study Overview
Brief Summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
- •Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
- •All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)
Exclusion Criteria
- •Severe hypertension
- •Pregnant or nursing (lactating) women
- •Pre-menopausal women not taking accepted form of birth control
- •Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- •History of cardiovascular conditions
- •Uncontrolled Type 1 or Type 2 diabetes mellitus
- •Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
Amlodipine 10 mg
Experimental
Amlodipine 10 mg
Intervention: Amlodipine 10 mg (Drug)
Aliskiren/Amlodipine 150/10 mg
Experimental
Aliskiren/Amlodipine 150/10 mg
Intervention: Amlodipine 10 mg (Drug)
Aliskiren/Amlodipine 150/10 mg
Experimental
Aliskiren/Amlodipine 150/10 mg
Intervention: Aliskiren 150 (Drug)
Aliskiren/Amlodipine 300/10 mg
Experimental
Aliskiren/Amlodipine 300/10 mg
Intervention: Amlodipine 10 mg (Drug)
Aliskiren/Amlodipine 300/10 mg
Experimental
Aliskiren/Amlodipine 300/10 mg
Intervention: Amlodipine 300 (Drug)
Outcomes
Primary Outcomes
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
Time Frame: Baseline and Week 8
Secondary Outcomes
- Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group(8 weeks)
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study(Baseline and Week 8)
- Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)(12 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren AloneHypertensionNCT00777946Novartis818
Completed
Phase 4
Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II HypertensionStage II HypertensionNCT01070030Novartis230
Completed
Phase 3
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for HypertensionHypertensionNCT00797862Novartis1,254
Completed
Phase 4
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic HypertensionHypertensionNCT00942994Novartis412
Completed
Phase 3
A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe HypertensionHypertensionNCT00219050Novartis180