Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day

Official Title: “Efficacy of a Combination of Amlodipine / Valsartan on Blood Pressure Control, With One Nocturnal or Diurnal Intake a Day, in Ambulatory Blood Pressure Monitoring Setting, in Essential Uncontrolled Hypertensive Patients With Amlodipine 5mg ; The ExPERT Study”

This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.

Intervention(s) in this Clinical Trial

• Drug: Amlodipine
  • 5 mg or 10 mg tablets.
• Drug: Valsartan
  • 160 mg capsules.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Morning Intake
  • After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
• Experimental: Evening Intake
  • After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.

Primary Measures

• Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring
  • Time Frame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
    Safety Issue?: No

Secondary Measures

• Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
  • Time Frame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
    Safety Issue?: No
• Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
  • Time Frame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
    Safety Issue?: No
• Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
  • Time Frame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
    Safety Issue?: No
• Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
  • Time Frame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
    Safety Issue?: No
• Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure
  • Time Frame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
    Safety Issue?: No
• Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure
  • Time Frame: Screening visit (Week -4, prior to 4-week open-label screening phase) and Week 8 (after 8 weeks of combination therapy)
    Safety Issue?: No
• Percentage of Participants With 24-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 125/80 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
  • Time Frame: Visit 4 (week 8)
    Safety Issue?: No
• Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
  • Time Frame: Visit 4 (week 8)
    Safety Issue?: No
• Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
  • Time Frame: Visit 4 (week 8)
    Safety Issue?: No
• Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint
  • Time Frame: Visit 4 (week 8)
    Safety Issue?: No

Inclusion Criteria:

• Age >= 18 years
• Essential uncontrolled or naive hypertensive patients (SBP ≥= 140 mmHG, DBP - >/=90 mm Hg, or SBP >= 130 mmHg, DBP >= 80 mmHg if diabetes or renal impairment) except patients treated with amlodipine, or intolerant of ARBs and/or calcium channel blockers.

Exclusion Criteria:

• Severe hypertension : SBP >= 180 mmHg, DBP >= 110mmHg
• Pregnancy
• Allergia to ARBs and/or to calcium channel blockers
• Antihypertensive tritherapy at V1
• History of heart failure, pectoris angina, stroke, myocardial infarction
• Diabetes type I
• Renal impairment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Roland Asmar Principal Investigator principle investigator; Institut cardiovasculaire 75016 Paris  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700271

Study ID Number: CVAA489AFR01

ClinicalTrials.gov Identifier: NCT00700271

Health Authority: France: Afssaps - French Health Products Safety Agency