Clinical trial NCT00700271: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
ambulatory blood pressure monitoring
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring
timeFrame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
Secondary outcomes:
measure: Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
timeFrame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
measure: Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
timeFrame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
measure: Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
timeFrame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
measure: Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring
timeFrame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
measure: Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure
timeFrame: Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)
measure: Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure
timeFrame: Screening visit (Week -4, prior to 4-week open-label screening phase) and Week 8 (after 8 weeks of combination therapy)
measure: 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
timeFrame: Visit 4 (week 8)
measure: Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
timeFrame: Visit 4 (week 8)
measure: Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring
timeFrame: Visit 4 (week 8)
measure: Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint
timeFrame: Visit 4 (week 8)
Other outcomes:
Locations:
city: Paris
country: France
facility: Investigative sites in France
city: Tunisia
country: Tunisia
facility: Investigative sites in Tunisia
Study officials:
affiliation: principle investigator; Institut cardiovasculaire 75016 Paris
name: Roland Asmar
role: PRINCIPAL_INVESTIGATOR
References: