A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension
NCT ID: NCT01256411
Last Updated: 2015-10-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
341 participants
INTERVENTIONAL
2010-11-30
2012-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
NCT01615198
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension
NCT01785472
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
NCT00549770
Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients
NCT02515331
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
NCT01599104
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LCZ696
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.
Exclusion Criteria
* Presence of significant protocol violation in CLCZ696A2219.
* Patients who are deemed to be unable to comply with the protocol by the investigator.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Shimotsuke, Tochigi, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site
Chiyoda-ku, Tokyo, Japan
Novartis Investigative Site
Kiyose, 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
Ōta-ku, Tokyo, 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
Bucheon-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Koyang, Kyunggi, South Korea
Novartis Investigative Site
Daegu, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Taichung, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Taipei, Taiwan, Taiwan
Novartis Investigative Site
Changhua, , Taiwan
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLCZ696A2219E1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.