Back to resultsEfficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Amlodipine
Olmesartan medoxomil
Amlodipine+valsartan
Hydrochlorothiazide
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, valsartan, amlodipine
Eligibility Criteria
Inclusion Criteria for Core study:
- Male or female patients (>=18 years)
- Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
- Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)
Inclusion Criteria for Extension:
- Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.
Exclusion Criteria for Core study:
- Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
- Pregnant or nursing women
- Treated hypertensive patients with controlled hypertension under current therapy
- A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
Exclusion Criteria for Extension:
- prematurely discontinued the core study
- failed to comply with the core study protocol
Other protocol-defined inclusion/exclusion criteria applied to the study.
Sites / Locations
- Novartis Investigative Site, , Germany
- 30 sites in Germany
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
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 Extension Phase of the Study
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
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
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
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 Core Phase of the Study
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
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 Core Phase of the Study
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
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 Extension Phase of the Study
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
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00523744
Brief Title
Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Official Title
An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, valsartan, amlodipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil
Intervention Description
Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.
Intervention Type
Drug
Intervention Name(s)
Amlodipine+valsartan
Other Intervention Name(s)
Exforge
Intervention Description
Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Other Intervention Name(s)
Sandoz
Intervention Description
Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.
Primary Outcome Measure Information:
Title
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
Description
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.
Time Frame
Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Title
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
Description
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.
Time Frame
Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Secondary Outcome Measure Information:
Title
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
Description
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.
Time Frame
Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Title
Change in Sitting Pulse Pressure During the Core Phase of the Study
Description
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.
Time Frame
Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Title
Change in Sitting Pulse Rate During the Core Phase of the Study
Description
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Time Frame
Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Title
Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
Description
Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
Time Frame
Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Title
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
Description
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.
Time Frame
Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)
Title
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
Description
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.
Time Frame
Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Title
Change in Sitting Pulse Pressure During the Extension Phase of the Study
Description
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.
Time Frame
Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Title
Change in Sitting Pulse Rate During the Extension Phase of the Study
Description
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Time Frame
Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)
Title
Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
Description
Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
Time Frame
Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Title
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study
Description
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.
Time Frame
Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Core study:
Male or female patients (>=18 years)
Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)
Inclusion Criteria for Extension:
- Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.
Exclusion Criteria for Core study:
Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
Pregnant or nursing women
Treated hypertensive patients with controlled hypertension under current therapy
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
Exclusion Criteria for Extension:
prematurely discontinued the core study
failed to comply with the core study protocol
Other protocol-defined inclusion/exclusion criteria applied to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site, , Germany
City
Schwerin
Country
Germany
Facility Name
30 sites in Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
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