PER-091-06
Completed
未知
An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
OVARTIS BIOSCIENSES PERU S.A.,0 sites0 target enrollmentJanuary 18, 2007
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -I10 Essential (primary) hypertension
- Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Outpatients 18 years of age and older.
- •2\) Male or female patients are eligible.
- •3\) Patients with a diagnosis of hypertension.
- •4\) Patients who are eligible and able to participate in the study, and who have given their consent after the purpose and nature of the research has been clearly explained to them.
Exclusion Criteria
- •1\. Women who are pregnant or breastfeeding.
- •2\. Women with reproductive potential, UNLESS they meet the definition of a postmenopausal woman OR who are using one or more of the acceptable methods of contraception.
- •3\. Severe hypertension.
- •4\. History or evidence of a secondary form of hypertension.
- •5\. Known Keith\-Wagener hypertensive retinopathy Grade III or IV.
- •6\. Current or previous diagnosis of heart failure.
- •7\. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- •8\. Serum potassium \<3\.5 mEq / L or ≥ 5\.3 mEq / L, serum sodium less than the normal limit or dehydration.
- •9\. Patients with type 1 or type 2 diabetes mellitus that are not well controlled.
- •10\. Current pectoris angina that requires pharmacological therapy.
Outcomes
Primary Outcomes
Not specified
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