Clinical trial NCT01593787: Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
Official title: A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension With Renal Dysfunction
Keywords: Hypertension
Renal dysfunction
LCZ696
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 32
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 hypertensive patients with renal dysfunction.


Eligibility criteria: Inclusion Criteria:

* Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
* Satisfy office msSBP ≥140 mmHg and \<180 mmHg at baseline.

Exclusion Criteria:

* Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
* History of angioedema, drug-related or otherwise, as reported by the patient.
* Any other following renal disorder:
* Patients show eGFR \< 15mL/min/1.73m\^2
* Patients on dialysis
* 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 Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
timeFrame: baseline, 8 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8
timeFrame: baseline, 8 weeks
measure: Percentage of Participants Achieving a Successful BP Control at Week 8
timeFrame: 8 weeks
measure: Percentage of Participants Achieving SBP Control at Week 8
timeFrame: 8 weeks
measure: Percentage of Participants Achieving DBP Control at Week 8
timeFrame: 8 weeks
measure: Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8
timeFrame: 8 weeks
measure: Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Aira-city
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Fujimino
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Osaka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ito S, Satoh M, Tamaki Y, Gotou H, Charney A, Okino N, Akahori M, Zhang J. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015 Apr;38(4):269-75. doi: 10.1038/hr.2015.1. Epub 2015 Feb 19.