A Phase 3 interventional study of irbesartan/amlodipine and irbesartan in Hypertension, sponsored by Sanofi. Completed at 38 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-26.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 10 weeks of treatment (W10)
Secondary Objective:
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 435 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
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Randomisation Criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 300/5 mg fixed combination for additional 5 weeks
Drug: irbesartan/amlodipine
Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan 150 mg for 5 weeks followed by irbesartan 300 mg for 5 additional weeks
Drug: irbesartan
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily
Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily
Mean home systolic blood pressure
Time frame: At randomisation and week 10
Mean office blood pressure
Time frame: At randomisation, week 5 and week 10
Mean home diastolic blood pressure
Time frame: At randomisation, week 5 and week 10
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Sanofi