Long term study of safety and efficacy of LCZ696 and LCZ696 combination with amlodipine in patients with hypertension

An open-label, long term (52 week) extension study to evaluate the safety, tolerability, and efficacy of treatment with LCZ696 monotherapy and LCZ696 in combination with amlodipine in patients with essential hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002306-31-SK

Enrollment

600

Registered

2013-11-11

Start date

2013-11-06

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential hypertension MedDRA version: 16.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Code: LCZ696 Pharmaceutical Form: Tablet INN or Proposed INN: Not established CAS Number: 936623-90-4 Other descriptive name: LCZ696 Concentration unit: mg milligram(s) Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent for the extension must be obtained before any assessment is performed. 2. Patients who have successfully completed protocol CLCZ696A2320 and are able to safely continue into the open-label extension as judged by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 476 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 124

Exclusion criteria

Exclusion criteria: 1. Patients who experienced a serious drug-related adverse event in study CLCZ696A2320. 2. Patients who develop a condition during the core study that would have excluded them from participation in the core study. 3. Patients with hypersensitivity to thiazide diuretics.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 26 weeks and 52 weeks;Secondary Objective: 1. To evaluate the long term efficacy of LCZ696 and the LCZ696/amlodipine combination as measured by change in msSBP and msDBP after 26 and 52 weeks of treatment in patients with essential hypertension. 2. To evaluate the proportion of patients achieving blood pressure control with LCZ696 and the LCZ696/ amlodipine combination (msSBP <140 mmHg and msDBP <90 mmHg) after 26 and 52 weeks of treatment. 3. To evaluate the proportion of patients achieving msSBP response (< 140 mmHg or = 20 mmHg reduction from baseline) and msDBP response (<90 mmHg or =10 mmHg reduction from baseline) after 26 and 52 weeks of treatment 4. To evaluate the change in pulse pressure of LCZ696 and the LCZ696/amlodipine combination treatment after 26 and 52 weeks of treatment.;Main Objective: To evaluate the long-term safety and tolerability of LCZ696 monotherapy and the LCZ696/amlodipine combination regimens in patients with essential hypertension after 26 and 52 weeks of treatment;Primary end point(s): Number of Adverse Events and Serious Adverse Events reported	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 26 weeks and 52 weeks;Secondary Objective: 1. To evaluate the long term efficacy of LCZ696 and the LCZ696/amlodipine combination as measured by change in msSBP and msDBP after 26 and 52 weeks of treatment in patients with essential hypertension. 2. To evaluate the proportion of patients achieving blood pressure control with LCZ696 and the LCZ696/ amlodipine combination (msSBP <140 mmHg and msDBP <90 mmHg) after 26 and 52 weeks of treatment. 3. To evaluate the proportion of patients achieving msSBP response (< 140 mmHg or = 20 mmHg reduction from baseline) and msDBP response (<90 mmHg or =10 mmHg reduction from baseline) after 26 and 52 weeks of treatment 4. To evaluate the change in pulse pressure of LCZ696 and the LCZ696/amlodipine combination treatment after 26 and 52 weeks of treatment.;Main Objective: To evaluate the long-term safety and tolerability of LCZ696 monotherapy and the LCZ696/amlodipine combination regimens in patients with essential hypertension after 26 and 52 weeks of treatment;Primary end point(s): Number of Adverse Events and Serious Adverse Events reported

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline in mean sitting systolic blood pressure 2. Change from baseline in mean sitting diastolic blood pressure 3. Percentage of patients achieving blood pressure control 4. Percentage of patients achieving successful systolic blood pressure response 5. Percentage of patients achieving successful diastolic blood pressure response 6. Percentage of patients achieving successful diastolic blood pressure response;Timepoint(s) of evaluation of this end point: 26 weeks and 52 weeks for all end points	—

Measure

Time frame

Secondary end point(s): 1. Change from baseline in mean sitting systolic blood pressure 2. Change from baseline in mean sitting diastolic blood pressure 3. Percentage of patients achieving blood pressure control 4. Percentage of patients achieving successful systolic blood pressure response 5. Percentage of patients achieving successful diastolic blood pressure response 6. Percentage of patients achieving successful diastolic blood pressure response;Timepoint(s) of evaluation of this end point: 26 weeks and 52 weeks for all end points

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Countries

Argentina, Brazil, Colombia, Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Peru, Philippines, Russian Federation, Slovakia, South Africa, Spain, Thailand, United States, Vietnam

Contacts

Public ContactDRA Department

Novartis Slovakia s.r.o.

DRA.Slovakia@novartis.com+421250706111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026