Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

Severe Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646671
• Other study ID #: CLCZ696A1305
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2012
• Last updated: October 2, 2015
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Severe Hypertension

Intervention

Drug:
• LCZ696
LCZ696 200 mg tablet once daily
• LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily
• LCZ696
2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Shibuya-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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). 2015 Sep 24. doi: 10.1111/jch.12667. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths	Adverse events, serious adverse events deaths were monitored from screening to week 8.	Week 8	Yes
Secondary	Change From Baseline in msSBP and msDBP at Week 8	Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.	Baseline, 8 weeks	No
Secondary	Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study	Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.	8 weeks	No
Secondary	Percentage of Participants Achieving Successful msSBP Control at End of Study	Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.	8 weeks	No
Secondary	Percentage of Participants Achieving Successful msDBP Control at End of Study	Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.	8 weeks	No
Secondary	Percentage of Participants With SBP Response at End of Study	SBP response was defined as <140 mmHg or a reduction = 20 mmHg from baseline.	Baseline, 8 weeks	No
Secondary	Percentage of Participants With DBP Response at End of Study	DBP response was defined as <90 mmHg or a reduction = 10 mmHg from baseline.	Baseline, 8 weeks	No