Phase 4 N=393 Randomized Treatment

Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00687973 ↗

Enrolled (actual)

393

Serious AEs

1.4%

Results posted

Jan 2011

Primary outcome: Primary: Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) — -13.65; -9.7 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Valsartan/amlodipine 80/5 mg tablets (Drug); Amlodipine 5 mg capsules (Drug); Amlodipine 10 mg capsules (Drug); Atenolol 50 mg tablets (Drug); Atenolol 100 mg tablets (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)	-13.65; -9.7	—
SECONDARY Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)	-10.92; -8.3	—
SECONDARY Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)	-5.5; -1.7	—
SECONDARY Change From Baseline of Augmentation Index (Aix) at Week 8	-2.21; 3.61	—
SECONDARY Change From Baseline of Aix at Week 24	-4.10; 2.40	—
SECONDARY Change From Baseline of Aix Corrected to Heart Rate at Week 24	-4.12; -2.43	—
SECONDARY Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)	-0.98; -0.95	—
SECONDARY Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)	-12.93; -11.78; -7.85; -7.94	—
SECONDARY Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)	-5.02; -3.66	—
SECONDARY Change From Baseline of SBP/DBP at Week 24 (Office BP)	-14.49; -16.94; -8.17; -10.45	—
SECONDARY Change From Baseline of Pulse Pressure at Week 24 (Office BP)	-6.32; -6.48	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00687973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.