Back to resultsEffect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg (EXPLOR)
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Valsartan/amlodipine 80/5 mg tablets
Amlodipine 5 mg capsules
Amlodipine 10 mg capsules
Atenolol 50 mg tablets
Atenolol 100 mg tablets
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Male or female patients 18 years of age or older
- Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
- Written informed consent to participate in the study prior to any study procedures
Exclusion Criteria:
- Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
- Evidence of a secondary form of hypertension
- Type 1 diabetes mellitus
- History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
Sites / Locations
- 2 & 4 rue Lionel Terray BP 308
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Valsartan/amlodipine 160/10 mg
Atenolol/amlodipine 100/10 mg
Arm Description
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Outcomes
Primary Outcome Measures
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
Secondary Outcome Measures
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)
Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)
Change From Baseline of Augmentation Index (Aix) at Week 8
To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.
Change From Baseline of Aix at Week 24
Change From Baseline of Aix Corrected to Heart Rate at Week 24
The heart rate correction was computed by a multivariate model analysis
Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)
Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)
Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.
Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)
Change From Baseline of SBP/DBP at Week 24 (Office BP)
Change From Baseline of Pulse Pressure at Week 24 (Office BP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00687973
Brief Title
Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
Acronym
EXPLOR
Official Title
Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
393 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valsartan/amlodipine 160/10 mg
Arm Type
Experimental
Arm Description
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Arm Title
Atenolol/amlodipine 100/10 mg
Arm Type
Active Comparator
Arm Description
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Intervention Type
Drug
Intervention Name(s)
Valsartan/amlodipine 80/5 mg tablets
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5 mg capsules
Intervention Type
Drug
Intervention Name(s)
Amlodipine 10 mg capsules
Intervention Type
Drug
Intervention Name(s)
Atenolol 50 mg tablets
Intervention Type
Drug
Intervention Name(s)
Atenolol 100 mg tablets
Primary Outcome Measure Information:
Title
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)
Time Frame
Baseline and Week 8
Title
Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)
Time Frame
Baseline and Week 24
Title
Change From Baseline of Augmentation Index (Aix) at Week 8
Description
To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.
Time Frame
Baseline and Week 8
Title
Change From Baseline of Aix at Week 24
Time Frame
Baseline and Week 24
Title
Change From Baseline of Aix Corrected to Heart Rate at Week 24
Description
The heart rate correction was computed by a multivariate model analysis
Time Frame
Baseline and Week 24
Title
Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)
Time Frame
Baseline and Week 24
Title
Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)
Description
Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.
Time Frame
Baseline and Week 24
Title
Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)
Time Frame
Baseline and Week 24
Title
Change From Baseline of SBP/DBP at Week 24 (Office BP)
Time Frame
Baseline and Week 24
Title
Change From Baseline of Pulse Pressure at Week 24 (Office BP)
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients 18 years of age or older
Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
Written informed consent to participate in the study prior to any study procedures
Exclusion Criteria:
Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
Evidence of a secondary form of hypertension
Type 1 diabetes mellitus
History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
2 & 4 rue Lionel Terray BP 308
City
Rueil-Malmaison
ZIP/Postal Code
92506
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
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