Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension

• Status: Withdrawn
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in combination with amlodipine in patients with essential hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine; LCZ 696; Sacubitril and valsartan sodium hydrate drug combination

Criteria

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.

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 Other protocol defined inclusion/exclusion criteria may apply