Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615198
• Other study ID #: CLCZ696A2316
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2012
• Last updated: October 1, 2015
• Start date: August 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationKorea: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency, Ministry of Health, Labor and WelfareTaiwan: Department of HealthThailand: Ministry of Public HealthHong Kong: Department of HealthPhilippines: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients must give written informed consent before any assessment is performed

• Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure = 150 mmHg and < 180 mmHg

• Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

Exclusion criteria:

• Patients with severe hypertension (msDBP = 110 mmHg and/or msSBP =180 mmHg). Patients with history of angioedema, drug-related or otherwise

• Patients with 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 any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.

• Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).

• Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication

• Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).

• Patients with a clinically significant valvular heart disease at the time of screening

• Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Olmesartan
10 mg, 20 mg, 40 mg capsules
• Placebo
Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
• LCZ696
100 mg, 200 mg tablets

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Xi'an	Shanxi
Hong Kong	Novartis Investigative Site	Hong Kong	Shatin, NT
Hong Kong	Novartis Investigative Site	Hong Kong
Japan	Novartis Investigative Site	Asahikawa	Hokkaido
Japan	Novartis Investigative Site	Chikushi-gun	Fukuoka
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Fujimino	Saitama
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hachioji	Tokyo
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hiki-Gun	Saitama
Japan	Novartis Investigative Site	Katsushika-ku	Tokyo
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Koshigaya city	Saitama
Japan	Novartis Investigative Site	Kunitachi	Tokyo
Japan	Novartis Investigative Site	Kyotanabe-city	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Meguro-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Shibuya-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Suita-city	Osaka
Japan	Novartis Investigative Site	Tachikawa	Tokyo
Japan	Novartis Investigative Site	Taito	Tokyo
Japan	Novartis Investigative Site	Tokorozawa-city	Saitama
Japan	Novartis Investigative Site	Toon-city	Ehime
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Toyonaka-city	Osaka
Korea, Republic of	Novartis Investigative Site	Bucheon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Daejeon
Korea, Republic of	Novartis Investigative Site	Goyang	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Jeonju-si	Jeollabuk-do
Korea, Republic of	Novartis Investigative Site	Koyang	Kyunggi
Korea, Republic of	Novartis Investigative Site	Seongnam	Gyeonggi
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City
Philippines	Novartis Investigative Site	Quezon City	Manila
Philippines	Novartis Investigative Site	Valenzuela City
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung	Taiwan ROC
Taiwan	Novartis Investigative Site	Taipei	Taiwan, ROC
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,  Hong Kong,  Japan,  Korea, Republic of,  Philippines,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.	Baseline, 10 weeks	No
Secondary	Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)	ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.	Baseline, 10 weeks	No
Secondary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)	Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.	Baseline, 4 weeks, 14 weeks	No
Secondary	Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)	ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.	Baseline, 10 weeks	No
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.	Baseline, 10 weeks	No
Secondary	Change From Baseline in Mean Sitting Pulse Pressure	Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.	Baseline, 4 weeks, 10 weeks, 14 weeks	No
Secondary	Change From Baseline in Daytime and Nighttime maSBP/maDBP	ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.	Baseline, 10 weeks	No
Secondary	Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers	ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop = 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.	Baseline, 10 weeks	No
Secondary	Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers	ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop = 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.	Baseline, 10 weeks	No
Secondary	Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)	A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.	4 weeks, 10 weeks, 14 weeks	No
Secondary	Number of Participants Achieving Successful Response in msSBP and msDBP	Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.	4 weeks,10 weeks, 14 weeks	No
Secondary	Number of Participants With Adverse Events, Serious Adverse Events and Death	Adverse event monitoring was conducted throughout the study.	14 weeks	Yes