Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
Phase 4
Completed
- Conditions
- Hypertension
- Interventions
- Drug: Valsartan/amlodipine 80/5 mg tablets
- Registration Number
- NCT00687973
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 393
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atenolol/amlodipine 100/10 mg Atenolol 50 mg tablets 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. Atenolol/amlodipine 100/10 mg Atenolol 100 mg tablets 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. Atenolol/amlodipine 100/10 mg Amlodipine 10 mg capsules 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. Valsartan/amlodipine 160/10 mg Valsartan/amlodipine 80/5 mg tablets 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. Atenolol/amlodipine 100/10 mg Amlodipine 5 mg capsules 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.
- Primary Outcome Measures
Name Time Method Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) Baseline and Week 24
- Secondary Outcome Measures
Name Time Method Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement) Baseline and Week 8 Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement) Baseline and Week 24 Change From Baseline of Augmentation Index (Aix) at Week 8 Baseline and 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 Baseline and Week 24 Change From Baseline of Aix Corrected to Heart Rate at Week 24 Baseline and 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) Baseline and Week 24 Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center) Baseline and Week 24 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) Baseline and Week 24 Change From Baseline of SBP/DBP at Week 24 (Office BP) Baseline and Week 24 Change From Baseline of Pulse Pressure at Week 24 (Office BP) Baseline and Week 24
Trial Locations
- Locations (1)
2 & 4 rue Lionel Terray BP 308
🇫🇷Rueil-Malmaison, France