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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00687973
First received: March 20, 2008
Last updated: March 8, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Hypertension
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline of Augmentation Index (Aix) at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline of Aix Corrected to Heart Rate at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    The heart rate correction was computed by a multivariate model analysis

  • Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline of SBP/DBP at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline of Pulse Pressure at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Enrollment: 393
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687973

Locations
France
2 & 4 rue Lionel Terray BP 308
Rueil-Malmaison, France, 92506
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00687973     History of Changes
Other Study ID Numbers: CVAA489AFR02
Study First Received: March 20, 2008
Results First Received: December 22, 2010
Last Updated: March 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Amlodipine, valsartan drug combination
Atenolol
Valsartan
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014