An 8-week study to evaluate the efficacy (blood pressure lowering effect) and safety of LCZ696 given alone and in combination with amlodipine

• Conditions: Essential hypertension; MedDRA version: 16.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001643-30-ES
• Lead Sponsor: ovartis Farmacéutica S. A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-12
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1386

Inclusion Criteria

1.Male or female outpatients.
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 visit.
6.Ability to communicate and comply with all study requirements and demonstrate good medication compliance (? 80% compliance rate) during the treatment run-in period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 286

Exclusion Criteria

1.Severe hypertension (msDBP ?110 mmHg and/or msSBP ? 180 mmHg).
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 drug- induced 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified