Phase 4
Completed N=546
Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day
Source: ClinicalTrials.gov NCT00700271 ↗Enrolled (actual)
546
Serious AEs
0.7%
Results posted
Jan 2011
Primary outcomePrimary: Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring — -12.01; -11.3 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring |
-12.01; -11.3 | — |
| SECONDARY Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring |
-13.50; -11.99; -7.56; -7.11 | — |
| SECONDARY Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring |
-9.68; -10.33; -5.01; -6.3 | — |
| SECONDARY Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring |
-6.53; -6.79 | — |
| SECONDARY Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring |
-12.16; -11.37; -7.71; -7.01 | — |
| SECONDARY Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure |
-18.7; -17.3; -10.1; -8.6 | — |
| SECONDARY Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure |
-32.2; -29; -16.6; -14.3 | — |
| SECONDARY 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 |
47.6; 46.9 | — |
| SECONDARY Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring |
65.3; 58.2 | — |
| SECONDARY Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring |
41.3; 46.8 | — |
| SECONDARY Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint |
71.1; 72.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00700271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.