Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine

Novartis Pharmaceuticals266 enrolled

Overview

This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

266

Conditions

Essential Hypertension

Interventions

LCZ696DRUG

LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.

AmlodipineDRUG

Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.

PlaceboDRUG

Matching placebo to LCZ696

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients must give written informed consent and have a diagnosis of hypertension: Untreated patients must have an msSBP ≥ 150 mmHg and \< 180 mmHg at both Visit 1 and Visit 101. Pre-treated patients must have an msSBP ≥ 145 mmHg and \< 180 mmHg after wash out at Visit 101. All patients must have an office msSBP ≥ 145 mmHg and \< 180 mmHg at the completion of the 4-week run-in epoch (at the randomization visit (Visit 201). Patients must successfully complete ABPM and pass technical requirements at Visit 201. Exclusion Criteria: Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg). History of angioedema, drug-related or otherwise. 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 PCI during the 12 months prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply

Locations (28)

Novartis Investigative Site

Outcomes

Primary Outcomes

Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)

The change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups was measured. A greater reduction from baseline in the LCZ696 group indicates a positive treatment effect.

Time frame: 8 weeks

Secondary Outcomes

Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)

The change in mean 24 hour maDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.

Time frame: 8 weeks

Change in Mean Sitting Systolic Blood Pressure (msSBP)

The change in the patient's msSBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.

Time frame: 8 weeks

Change in Mean Sitting Diastolic Blood Pressure (msDBP)

The change in the patient's msDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.

Time frame: 8 weeks

Change in Sitting Pulse Pressure (PP)

The change in the patient's mean sitting PP from baseline to end of the study was measured. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.

Time frame: 8 weeks

Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)

The number of participants achieving a systolic and diastolic blood pressure \< 140/90 mmHg was measured. This outcome measure shows how well a given blood pressure treatment can achieve a given blood pressure target or goal. Participants who achieved the target blood pressure were determined based on the mean SBP and DBP measurements taken at the end of the study. If the participants' BP measurement was below the above target, they were considered to have successful blood pressure control.

Data from ClinicalTrials.gov

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