A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256411
• Other study ID #: CLCZ696A2219E1
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2010
• Last updated: September 22, 2015
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug AdministrationKorea: Korea Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices AgencyTaiwan: Department of HealthThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.

• Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Exclusion Criteria:

• Patients who did not complete CLCZ696A2219.

• Presence of significant protocol violation in CLCZ696A2219.

• Patients who are deemed to be unable to comply with the protocol by the investigator.

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• LCZ696
Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.
• Amlodipine
Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.
• Hydrochlorothiazide (HCTZ)
Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Shijiazhuang	Hebei
China	Novartis Investigative Site	Tianjin
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Kunitachi	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Shimotsuke-city	Tochigi
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Korea, Republic of	Novartis Investigative Site	Bucheon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Koyang	Kyunggi
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)	Participants were monitored throughout the study for adverse events, serious adverse events and deaths.	Baseline to 12 months	Yes
Secondary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)	Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.	Baseline, 12 months	No
Secondary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)	Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.	Baseline, 12 months	No
Secondary	Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)	Blood pressure (BP) control is defined as BP <140/90 mmHg.	Baseline to 12 months	No
Secondary	Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)	Blood pressure (BP) control is defined as BP <140/90 mmHg.	Baseline to 12 months	No