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OpenTrials
Completed

NCT Number: NCT00687973

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

2 & 4 rue Lionel Terray BP 308

Rueil-Malmaison, 92506, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)

    Time frame: Baseline and Week 24

Secondary outcomes

  1. Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)

    Time frame: Baseline and Week 8

  2. Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)

    Time frame: Baseline and Week 24

  3. Change From Baseline of Augmentation Index (Aix) at Week 8

    Time frame: 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.

  4. Change From Baseline of Aix at Week 24

    Time frame: Baseline and Week 24

  5. Change From Baseline of Aix Corrected to Heart Rate at Week 24

    Time frame: Baseline and Week 24

    The heart rate correction was computed by a multivariate model analysis

  6. Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)

    Time frame: Baseline and Week 24

  7. Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)

    Time frame: 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.

  8. Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)

    Time frame: Baseline and Week 24

  9. Change From Baseline of SBP/DBP at Week 24 (Office BP)

    Time frame: Baseline and Week 24

  10. Change From Baseline of Pulse Pressure at Week 24 (Office BP)

    Time frame: Baseline and Week 24

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: EXPLOR

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 2, 2008
Registry last updated
Mar 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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