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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.

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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.
  • 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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.
  • 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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.
  • 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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.
  • 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)
    • At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.
  • 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)
    • At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.
  • 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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.
  • 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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.
  • 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)
    • Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.
  • 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)
    • At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for 5 minutes; the investigator then took 3 blood pressure and 1 pulse rate reading. The measurements were recorded at 1-2 minute intervals. BP Control is defined as msSBP/msDBP <149/90 mmHg and/or <130/80 mmHg if diabetes or renal insufficiency (RI).

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • External Affairs, Novartis Pharmaceuticals
  • Overall Official(s)
    • Roland Asmar, Principal Investigator, principle investigator; Institut cardiovasculaire 75016 Paris

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