A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-06-30

Brief Summary

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This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sacubitril/valsartan (LCZ696)

Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks.

Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.

Group Type EXPERIMENTAL

sacubitril/valsartan (LCZ696)

Intervention Type DRUG

200 mg tablets

placebo to olmesartan

Intervention Type OTHER

placebo

Amlodipine (Optional)

Intervention Type DRUG

If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

olmesartan

Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks.

Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.

Group Type ACTIVE_COMPARATOR

olmesartan

Intervention Type DRUG

placebo to sacubitril/valsartan (LCZ696)

Intervention Type OTHER

placebo

Amlodipine (Optional)

Intervention Type DRUG

If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

Interventions

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sacubitril/valsartan (LCZ696)

200 mg tablets

Intervention Type DRUG

olmesartan

Intervention Type DRUG

placebo to sacubitril/valsartan (LCZ696)

placebo

Intervention Type OTHER

placebo to olmesartan

placebo

Intervention Type OTHER

Amlodipine (Optional)

If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with essential hypertension, untreated or currently taking antihypertensive therapy

Exclusion Criteria

* women of child bearing potential (WOCBP) if not on highly effective contraception
* Malignant or severe hypertension (grade 3 of WHO classification)
* History or evidence of a secondary form of hypertension
* Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
* Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No