Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
- Conditions
- Hypertension
- Interventions
- Drug: Aliskiren/Amlodipine 300/5 mgDrug: Aliskiren/Amlodipine 300/10 mgDrug: Placebo to Aliskiren/Amlodipine
- Registration Number
- NCT00777946
- Lead Sponsor
- Novartis
- Brief Summary
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 818
- Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (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 4
- Severe hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
- Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aliskiren 300 mg/Amlodipine 5 mg Placebo to Aliskiren Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. Aliskiren 300 mg/Amlodipine 5 mg Aliskiren/Amlodipine 300/5 mg Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. Aliskiren 300 mg/Amlodipine 10 mg Aliskiren/Amlodipine 300/10 mg Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. Aliskiren 300 mg/Amlodipine 10 mg Placebo to Aliskiren Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. Aliskiren 300 mg Aliskiren 300 mg Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. Aliskiren 300 mg Placebo to Aliskiren/Amlodipine Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) Baseline, End of Study (Week 8) After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
- Secondary Outcome Measures
Name Time Method Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) Baseline, End of Study (Week 8) After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.
Number of Participants With Serious Adverse Events and Adverse Events 8 weeks The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.
Additional information about Adverse Events can be found in the Adverse Event Section.Percentage of Participants Achieving Blood Pressure Control 8 weeks After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure \<90 and a mean sitting Systolic Blood Pressure \<140.Percentage of Participants Achieving a Diastolic Blood Pressure Response 8 weeks After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) \<90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline.Percentage of Participants Achieving a Systolic Blood Pressure Response 8 weeks After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.
A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) \<140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline.
Trial Locations
- Locations (2)
Investigative Site
🇻🇪Venezuela, Venezuela
Investigative site
🇮🇹Italy, Italy