Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

Novartis

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Olmesartan; Drug: Placebo; Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01615198

CLCZ696A2316

Details and patient eligibility

About

The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

Enrollment: 588 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must give written informed consent before any assessment is performed
• Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg
• Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

Exclusion criteria

• Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
• Patients with history or evidence of a secondary form of hypertension
• Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
• History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
• Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
• Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
• Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
• Patients with a clinically significant valvular heart disease at the time of screening
• Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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588 participants in 2 patient groups

LCZ696

Experimental group

Description:

Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.

Treatment:

Drug: LCZ696

Drug: Placebo

Olmesartan

Active Comparator group

Description:

Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.

Treatment:

Drug: Placebo

Drug: Olmesartan