PER-072-13Unknown未知
AN 8-WEEK RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLEDFACTORIAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OFLCZ696 ALONE AND IN COMBINATION WITH AMLODIPINE INPATIENTS WITH ESSENTIAL HYPERTENSIO
OVARTIS BIOSCIENSES PERU S.A.,0 sites0 target enrollmentStarted: January 22, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
- Sex
- All
Inclusion Criteria
- •1. Male or female outpatients aged ≥ 18 years (at the time of
- •signing informed consent).
- •2. Patients with mild-to-moderate hypertension, untreated or
- •currently taking antihypertensive therapy
- •3. Treated patients (using antihypertensive treatments within 4
- •weeks prior to Visit 1) must have an msSBP ≥150 mmHg and
- •<180 mmHg at the randomization visit and msSBP ≥140
- •mmHg <180 mmHg at the preceding visit.
- •4. Untreated patients (newly diagnosed with essential
- •hypertension or having a history of hypertension but have not
- •been taking any antihypertensive drugs for at least 4 weeks
- •prior to Visit 1) must have an msSBP ≥150 mmHg and <180
- •mmHg at both the randomization visit and the preceding visit.
- •5. Patients must have an absolute difference of ≤15 mmHg in
- •msSBP between the randomization visit and the preceding
- •6. Ability to communicate and comply with all study
- •requirements and demonstrate good medication compliance (≥
- •80% compliance rate) during the treatment run-in period.
Exclusion Criteria
- •1. Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥
- •2. History of angioedema, drug-related or otherwise
- •3. History or evidence of a secondary form of hypertension,
- •including but not limited to any of the following: renal
- •parenchymal hypertension, renovascular hypertension
- •(unilateral or bilateral renal artery stenosis), coarctation of the
- •aorta, primary hyperaldosteronism, Cushing’s disease,
- •pheochromocytoma, polycystic kidney disease, and druginduced
- •hypertension
- •4. Transient ischemic cerebral attack (TIA) during the 12 months
- •prior to Visit 1 or any history of stroke
- •5. History of myocardial infarction, coronary bypass surgery or
- •any percutaneous coronary intervention (PCI) during the 12
- •months prior to Visit 1
- •6. Pregnant or lactating women
- •7. Women of child-bearing potential not using highly effective
- •methods of contraception
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