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

• Register: EUCTR
• Last refreshed on: 5 August 2014
• Main ID: EUCTR2013-002306-31-ES
• Date of registration: 12/11/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• Public title: Long term study of safety and efficacy of LCZ696 and LCZ696 combination with amlodipine in patients with hypertension
• Scientific title: 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
• Date of first enrolment: 27/01/2014
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002306-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 6

Countries of recruitment

Argentina, Brazil, Colombia, Dominican Republic, Ecuador, Guatemala, Mexico, Panama, Peru, Philippines, South Africa, Spain, Thailand, Vietnam

Contacts

• Name: Departamento Médico (ICRO)
• Affiliation: Novartis Farmacéutica, S.A.

• Name: Departamento Médico (ICRO)
• Affiliation: Novartis Farmacéutica, S.A.

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Intervention(s)

Product Code: LCZ696
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 936623-90-4
Current Sponsor code: LCZ696
Other descriptive name: LCZ696
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: amlodipine Hexal
Product Name: amlodipine besylate
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
Other descriptive name: AMLODIPINE BESILATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

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.

Primary end point(s): Number of Adverse Events and Serious Adverse Events
reported

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

Timepoint(s) of evaluation of this end point: 26 weeks and 52 weeks

Secondary Outcome(s)

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

Secondary ID(s)

CLCZ696A2320E1

Source(s) of Monetary Support

Novartis Pharma Services AG