Clinical trial NCT00687973: Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)
timeFrame: Baseline and Week 8
measure: Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)
timeFrame: Baseline and Week 24
measure: Change From Baseline of Augmentation Index (Aix) at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline of Aix at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline of Aix Corrected to Heart Rate at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)
timeFrame: Baseline and Week 24
measure: Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)
timeFrame: Baseline and Week 24
measure: Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)
timeFrame: Baseline and Week 24
measure: Change From Baseline of SBP/DBP at Week 24 (Office BP)
timeFrame: Baseline and Week 24
measure: Change From Baseline of Pulse Pressure at Week 24 (Office BP)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Rueil-Malmaison
country: France
facility: 2 & 4 rue Lionel Terray BP 308
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: