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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 393
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Rueil-Malmaison, France, 92506
    • 2 & 4 rue Lionel Terray BP 308

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Valsartan/amlodipine 160/10 mg; 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.	Drug: Valsartan/amlodipine 80/5 mg tablets
ACTIVE_COMPARATOR: Atenolol/amlodipine 100/10 mg; 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.	Drug: Amlodipine 5 mg capsules; Drug: Amlodipine 10 mg capsules; Drug: Atenolol 50 mg tablets; Drug: Atenolol 100 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline and Week 8
Change From Baseline of Aix at Week 24		Baseline and 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	Baseline and Week 24
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)	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.	Baseline and Week 24
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: March 20, 2008
• First Submitted That Met QC Criteria: May 30, 2008
• First Posted (ESTIMATE): June 2, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2011
• Last Update Submitted That Met QC Criteria: March 8, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Amlodipine; Valsartan; Atenolol
• Other Study ID Numbers: CVAA489AFR02