Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00523744
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).
- Detailed Description
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ Amlodipine+valsartan During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ Amlodipine During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ Olmesartan medoxomil During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ Hydrochlorothiazide During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
- Primary Outcome Measures
Name Time Method Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) 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 (Week 4) to end of Phase 2 (Week 8) 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 Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) Normalized Blood Pressure was defined as a msSBP \< 140 mmHg and/or a msDBP \< 90 mmHg.
Change in Sitting Pulse Pressure During the Core Phase of the Study Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) 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 a Protocol-defined Blood Pressure Response During the Core Phase of the Study Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8) Blood pressure response was defined as msSBP \< 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) 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 Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) 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 Extension Phase of the Study Baseline Phase 3 (Week 8) to end of Phase 3 (week 12) Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8) 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 (Week 4) to end of Phase 2 (Week 8) Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Change in Sitting Pulse Pressure During the Extension Phase of the Study Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) 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 Extension Phase of the Study Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12) Normalized Blood Pressure was defined as a msSBP \< 140 mmHg and/or a msDBP \< 90 mmHg.
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12) Blood pressure response was defined as msSBP \< 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP \< 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.
Trial Locations
- Locations (2)
30 sites in Germany
Novartis Investigative Site, , Germany
🇩🇪Schwerin, Germany