A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients. (ANDROMEDA)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.
Exclusion criteria
- BP> 180/110 mmHg
- Pregnant or nursing women
- Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month
- K <3.5 mEq/L or ≥ 5 mEq/L
- Renal impairment
- Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB
- Other protocol-defined inclusion/exclusion criteria may apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
253 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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