DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: Olmesartan (Drug); Placebo (Drug); LCZ696 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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

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

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Secondary outcome:

Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Change From Baseline in Mean Sitting Pulse Pressure

Change From Baseline in Daytime and Nighttime maSBP/maDBP

Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers

Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers

Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

Number of Participants Achieving Successful Response in msSBP and msDBP

Number of Participants With Adverse Events, Serious Adverse Events and Death

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Novartis Investigative Site, Beijing 100044, China

Novartis Investigative Site, Beijing 100020, China

Novartis Investigative Site, Shanghai 200025, China

Novartis Investigative Site, Tianjin 300142, China

Novartis Investigative Site, Hong Kong, Hong Kong

Novartis Investigative Site, Osaka 560-0005, Japan

Novartis Investigative Site, Saitama 337-0012, Japan

Novartis Investigative Site, Daegu 700-712, Korea, Republic of

Novartis Investigative Site, Daejeon 302-241, Korea, Republic of

Novartis Investigative Site, Incheon 400-711, Korea, Republic of

Novartis Investigative Site, Incheon 403-720, Korea, Republic of

Novartis Investigative Site, Seoul 100-380, Korea, Republic of

Novartis Investigative Site, Seoul 134-727, Korea, Republic of

Novartis Investigative Site, Seoul 135-720, Korea, Republic of

Novartis Investigative Site, Seoul 150-713, Korea, Republic of

Novartis Investigative Site, Seoul 150-950, Korea, Republic of

Novartis Investigative Site, Seoul 152-703, Korea, Republic of

Novartis Investigative Site, Quezon City 1100, Philippines

Novartis Investigative Site, Quezon City 1102, Philippines

Novartis Investigative Site, Valenzuela City 1441, Philippines

Novartis Investigative Site, Changhua 500, Taiwan

Novartis Investigative Site, Kaohsiung 807, Taiwan

Novartis Investigative Site, Taichung 40447, Taiwan

Novartis Investigative Site, Taipei 10002, Taiwan

Novartis Investigative Site, Taipei 114, Taiwan

Novartis Investigative Site, Taipei, Taiwan

Novartis Investigative Site, Bangkok 10400, Thailand

Novartis Investigative Site, Bangkok 10700, Thailand

Novartis Investigative Site, Chiang Mai 50200, Thailand

Novartis Investigative Site, Chongqing, Chongqing 400042, China

Novartis Investigative Site, Toon-city, Ehime 791-0295, Japan

Novartis Investigative Site, Chikushi-gun, Fukuoka 811-1244, Japan

Novartis Investigative Site, Fukuoka-city, Fukuoka 810-0066, Japan

Novartis Investigative Site, Kitakyushu-city, Fukuoka 807-0856, Japan

Novartis Investigative Site, Bucheon, Gyeonggi-do 424-717, Korea, Republic of

Novartis Investigative Site, Goyang, Gyeonggi-do 412-270, Korea, Republic of

Novartis Investigative Site, Asahikawa, Hokkaido 078-8214, Japan

Novartis Investigative Site, Sapporo-city, Hokkaido 062-0053, Japan

Novartis Investigative Site, Sapporo-city, Hokkaido 063-0842, Japan

Novartis Investigative Site, Sapporo, Hokkaido 003-0026, Japan

Novartis Investigative Site, Sapporo, Hokkaido 003-0825, Japan

Novartis Investigative Site, Changsha, Hunan 410003, China

Novartis Investigative Site, Jeonju-si, Jeollabuk-do 561-712, Korea, Republic of

Novartis Investigative Site, Suzhou, Jiangsu 215006, China

Novartis Investigative Site, Kawasaki-city, Kanagawa 210-0852, Japan

Novartis Investigative Site, Kyotanabe-city, Kyoto 610-0361, Japan

Novartis Investigative Site, Kyoto-city, Kyoto 615-8125, Japan

Novartis Investigative Site, Koyang, Kyunggi 410-719, Korea, Republic of

Novartis Investigative Site, Shenyang, Liaoning 110003, China

Novartis Investigative Site, Quezon City, Manila 1100, Philippines

Novartis Investigative Site, Manila, Metro Manila 1000, Philippines

Novartis Investigative Site, Suita-city, Osaka 565-0871, Japan

Novartis Investigative Site, Toyonaka-city, Osaka 560-0082, Japan

Novartis Investigative Site, Fujimino, Saitama 356-0053, Japan

Novartis Investigative Site, Hiki-Gun, Saitama 355-0328, Japan

Novartis Investigative Site, Koshigaya city, Saitama 343-0826, Japan

Novartis Investigative Site, Tokorozawa-city, Saitama 359-1161, Japan

Novartis Investigative Site, Bundang, Seongnam 463-707, Korea, Republic of

Novartis Investigative Site, Xi'an, Shanxi 710061, China

Novartis Investigative Site, Hong Kong, Shatin, NT, Hong Kong

Novartis Investigative Site, Taichung, Taiwan ROC 40201, Taiwan

Novartis Investigative Site, Taipei, Taiwan, ROC 112, Taiwan

Novartis Investigative Site, Edogawa-ku, Tokyo 133-0061, Japan

Novartis Investigative Site, Edogawa-ku, Tokyo 134-0084, Japan

Novartis Investigative Site, Hachioji-city, Tokyo 192-0918, Japan

Novartis Investigative Site, Hachioji, Tokyo 192-0046, Japan

Novartis Investigative Site, Katsushika-ku, Tokyo 124-0024, Japan

Novartis Investigative Site, Kiyose-city, Tokyo 204-0021, Japan

Novartis Investigative Site, Kunitachi, Tokyo 186-0001, Japan

Novartis Investigative Site, Meguro-ku, Tokyo 152-0031, Japan

Novartis Investigative Site, Minato-ku, Tokyo 105-7390, Japan

Novartis Investigative Site, Minato-ku, Tokyo 108-0075, Japan

Novartis Investigative Site, Shibuya-ku, Tokyo 150-0002, Japan

Novartis Investigative Site, Shinagawa-ku, Tokyo 141-0032, Japan

Novartis Investigative Site, Tachikawa, Tokyo 190-0013, Japan

Novartis Investigative Site, Taito, Tokyo 111-0052, Japan

Novartis Investigative Site, Toshima-ku, Tokyo 171-0021, Japan

Novartis Investigative Site, Hangzhou, Zhejiang 310006, China

Novartis Investigative Site, Hangzhou, Zhejiang 310013, China

Additional Information

Starting date: August 2012
Last updated: July 20, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017