Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00699192
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 965
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlodipine/Valsartan 5/80 mg Amlodipine 5 mg 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily Amlodipine/Valsartan 5/80 mg Valsartan 80 mg 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily Amlodipine/Valsartan 5/40 mg Valsartan 40 mg 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily Amlodipine 5 mg Placebo 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily Amlodipine 5 mg Amlodipine 5 mg 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
- Primary Outcome Measures
Name Time Method Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) Baseline to end of study (Week 8) At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
- Secondary Outcome Measures
Name Time Method Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) Baseline to end of study (Week 8) At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8 Baseline to end of study (Week 8) A systolic blood pressure response was defined as a msSBP \< 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8) End of study (Week 8) Systolic blood pressure control was defined as a msSBP \< 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) End of study (Week 8) Overall blood pressure control was defined as a msSBP \< 140 mmHg and msDBP \< 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Trial Locations
- Locations (15)
Investigative site Italy
🇮🇹Rome, Italy
Investigative sites Czech Republic
🇨🇿Praha, Czech Republic
Investigative site Sweden
🇸🇪Malmo, Sweden
Investigative site France
🇫🇷Paris, France
Investigative site Hungary
🇭🇺Budapest, Hungary
Investigative site Slovakia
🇸🇰Bratislava, Slovakia
Investigative site Germany
🇩🇪Berlin, Germany
Investigative site Spain
🇪🇸Valencia, Spain
Investigative site Poland
🇵🇱Warsaw, Poland
Sites in Czech Republic
🇨🇿Nachod, Czech Republic
Novartis Investigative site
🇨🇿Brno, Czech Republic
Investigative site Finland
🇫🇮Tampere, Finland
Investigative site Czech Republic
🇨🇿Chrudim, Czech Republic
Investigative sites Czech Repbulic
🇨🇿Hodonin, Czech Republic
Investigative site Czech Repbulic
🇨🇿Jicin, Czech Republic