Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension
1 other identifier
interventional
389
5 countries
34
Brief Summary
This study is a phase 2 study in patients with essential hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hypertension
Started Aug 2010
Shorter than P25 for phase_2 hypertension
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
August 19, 2015
CompletedFebruary 15, 2016
January 1, 2016
8 months
August 26, 2010
July 23, 2015
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.
Baseline, 8 weeks
Secondary Outcomes (12)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Baseline, 8 weeks
Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP
Baseline, 8 weeks
Change From Baseline in Daytime Mean Ambulatory DBP and SBP
Baseline, 8 weeks
Change From Baseline in Nighttime Mean Ambulatory DBP and SBP
Baseline, 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Baseline, 8 weeks
- +7 more secondary outcomes
Study Arms (4)
LCZ696 100 mg
EXPERIMENTALLCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
LCZ696 200 mg
EXPERIMENTALLCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
LCZ696 400 mg
EXPERIMENTALLCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
Placebo
PLACEBO COMPARATORPlacebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must give written informed consent before any assessment is performed.
- Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and \< 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and \< 180 mmHg).
- Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
- Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.
You may not qualify if:
- Patients with severe hypertension.
- Patients with history of angioedema, drug-related or otherwise
- Pregnant or nursing women
- Women of child-bearing potential , who do not use adequate birth control methods
- History or evidence of a secondary form of hypertension.
- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
- Diabetes mellitus.
- Previous or current diagnosis of heart failure (NYHA Class II-IV).
- Clinically significant valvular heart disease at the time of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Novartis Investigative Site
Shijiazhuang, Hebei, 050000, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300142, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310009, China
Novartis Investigative Site
Beijing, 100044, China
Novartis Investigative Site
Beijing, 100730, China
Novartis Investigative Site
Chongqing, 400042, China
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023, Japan
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-0031, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8655, Japan
Novartis Investigative Site
Chiyoda-ku, Tokyo, 100-0005, Japan
Novartis Investigative Site
Kiyose, Tokyo, 204-0021, Japan
Novartis Investigative Site
Kunitachi, Tokyo, 186-0001, Japan
Novartis Investigative Site
Minato-ku, Tokyo, 105-7390, Japan
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075, Japan
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-0053, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-0063, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021, Japan
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 424-717, South Korea
Novartis Investigative Site
Seoul, Korea, 137-701, South Korea
Novartis Investigative Site
Koyang, Kyunggi, 410-719, South Korea
Novartis Investigative Site
Daegu, 705-703, South Korea
Novartis Investigative Site
Seoul, 150-950, South Korea
Novartis Investigative Site
Seoul, 152-703, South Korea
Novartis Investigative Site
Taichung, Taiwan, 40447, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10002, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10449, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 114, Taiwan
Novartis Investigative Site
Changhua, 500, Taiwan
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Bangkok, 10700, Thailand
Novartis Investigative Site
Chiang Mai, 50200, Thailand
Related Publications (2)
Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.
PMID: 26280447DERIVEDKario K, Sun N, Chiang FT, Supasyndh O, Baek SH, Inubushi-Molessa A, Zhang Y, Gotou H, Lefkowitz M, Zhang J. Efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Asian patients with hypertension: a randomized, double-blind, placebo-controlled study. Hypertension. 2014 Apr;63(4):698-705. doi: 10.1161/HYPERTENSIONAHA.113.02002. Epub 2014 Jan 20.
PMID: 24446062DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
September 1, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
February 15, 2016
Results First Posted
August 19, 2015
Record last verified: 2016-01