Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension
- Conditions
- Hypertension
- Interventions
- Drug: Candesartan+HCTZ - Phase 1Drug: Aliskiren+HCTZ - Phase 2Drug: Aliskiren+HCTZ+amlodipine - Phase 3
- Registration Number
- NCT00867490
- Lead Sponsor
- Novartis
- Brief Summary
This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.
- Detailed Description
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine Candesartan+HCTZ - Phase 1 - Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine Aliskiren+HCTZ - Phase 2 - Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine Aliskiren+HCTZ+amlodipine - Phase 3 -
- Primary Outcome Measures
Name Time Method Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study Baseline Phase 3 to end of Phase 3 The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study Baseline Phase 2 to end of Phase 2 The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
- Secondary Outcome Measures
Name Time Method Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study Baseline Phase 2 to end of Phase 2 The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Change in Sitting Pulse Pressure During the Core Phase of the Study Baseline Phase 2 to end of Phase 2 Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study Baseline Phase 3 to end of Phase 3 Normalized was defined as a msSBP \< 140 mm Hg and/or a msDBP \< 90 mm Hg.
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study Baseline Phase 3 to end of Phase 3 The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Change in Sitting Pulse Rate During the Core Phase of the Study Baseline Phase 2 to end of Phase 2 Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study Baseline Phase 3 to end of Phase 3 Blood pressure response was defined as msSBP \< 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP \< 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.
Change in Sitting Pulse Pressure During the Extension Phase of the Study Baseline Phase 3 to end of Phase 3 Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Change in Sitting Pulse Rate During the Extension Phase of the Study Baseline Phase 3 to end of Phase 3 Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Trial Locations
- Locations (1)
Investigative Site
🇩🇪Chemnitz, Germany