Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension

Novartis

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193101

CLCZ696A2219

Details and patient eligibility

About

This study is a phase 2 study in patients with essential hypertension.

Enrollment: 389 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must give written informed consent before any assessment is performed.
2. Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).
3. Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
4. Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.

Exclusion criteria

1. Patients with severe hypertension.
2. Patients with history of angioedema, drug-related or otherwise
3. Pregnant or nursing women
4. Women of child-bearing potential , who do not use adequate birth control methods
5. History or evidence of a secondary form of hypertension.
6. History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
7. Diabetes mellitus.
8. Previous or current diagnosis of heart failure (NYHA Class II-IV).
9. Clinically significant valvular heart disease at the time of screening.

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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389 participants in 4 patient groups, including a placebo group

LCZ696 100 mg

Experimental group

Description:

LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.

Treatment:

Drug: Placebo

Drug: LCZ696

LCZ696 200 mg

Experimental group

Description:

LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.

Treatment:

Drug: Placebo

Drug: LCZ696

LCZ696 400 mg

Experimental group

Description:

LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.

Treatment:

Drug: Placebo

Drug: LCZ696

Placebo

Placebo Comparator group

Description:

Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.

Treatment:

Drug: Placebo