Clinical trial NCT01646671: Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients
Official title: A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Patients With Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Hypertension
Keywords: Hypertension, Severe, LCZ696
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

Detailed description: Summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Eligibility criteria: Inclusion Criteria:

* Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

Exclusion Criteria:

* Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg
* History of angioedema, drug-related or otherwise, as reported by the patient
* Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
* Patients have significant cardiovascular co-morbidities
* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths
timeFrame: Week 8
Secondary outcomes:
measure: Change From Baseline in msSBP and msDBP at Week 8
timeFrame: Baseline, 8 weeks
measure: Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study
timeFrame: 8 weeks
measure: Percentage of Participants Achieving Successful msSBP Control at End of Study
timeFrame: 8 weeks
measure: Percentage of Participants Achieving Successful msDBP Control at End of Study
timeFrame: 8 weeks
measure: Percentage of Participants With SBP Response at End of Study
timeFrame: Baseline, 8 weeks
measure: Percentage of Participants With DBP Response at End of Study
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kario K, Tamaki Y, Okino N, Gotou H, Zhu M, Zhang J. LCZ696, a First-in-Class Angiotensin Receptor-Neprilysin Inhibitor: The First Clinical Experience in Patients With Severe Hypertension. J Clin Hypertens (Greenwich). 2016 Apr;18(4):308-14. doi: 10.1111/jch.12667. Epub 2015 Sep 24.