Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochloro… (NCT00387517) | Clinical Trial Compass
CompletedPhase 3
Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension
United States, Germany726 participantsStarted 2006-10
Plain-language summary
The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female outpatients 18 years old or older.
* Patients with a diagnosis of hypertension defined as follows:
* Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= mmHg and \< 110 mmHg at Visit 1.
* All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= 85 mmHg and \< 110 mmHg at Visit 2.
* All patients must have a msDBP \>= 90 mmHg and \< 110 mmHg at Visit 5.
* Patients who are eligible and consent to participate in the study
Exclusion Criteria:
* Severe hypertension (msDBP \>= 110 mmHg and/or MSSBP \>=180 mmHg).
* Previous or current diagnosis of heart failure.
* History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
* Other protocol-defined inclusion/exclusion criteria may apply
What they're measuring
1
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.