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

NCT01646671 | Completed Phase 3 Results DMC

• 1 other identifier: CLCZ696A1305
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Severe Hypertension

Keywords

Hypertension, Severe, LCZ696

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change From Baseline in msSBP and msDBP at Week 8

  Baseline, 8 weeks

• Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study

  8 weeks

• Percentage of Participants Achieving Successful msSBP Control at End of Study

  8 weeks

• Percentage of Participants Achieving Successful msDBP Control at End of Study

  8 weeks

• Percentage of Participants With SBP Response at End of Study

  Baseline, 8 weeks

Study Arms (3)

LCZ696 200 mg

EXPERIMENTAL

All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.

Drug: LCZ696

LCZ696 400 mg

EXPERIMENTAL

All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.

Drug: LCZ696

LCZ696 400 mg plus other hypertension (HTN) medications

EXPERIMENTAL

All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.

Drug: LCZ696

Interventions

LCZ696 DRUG

LCZ696 200 mg tablet once daily

LCZ696 200 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Yokohama, Kanagawa, 231-0023, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 606-8507, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-0031, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0918, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-7390, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 143-0023, Japan

Location

Novartis Investigative Site

Shibuya-ku, Tokyo, 150-0002, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-0032, Japan

Location

Related 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). 2016 Apr;18(4):308-14. doi: 10.1111/jch.12667. Epub 2015 Sep 24.

  PMID: 26402918 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

+1-862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 23, 2015
• Results First Posted: September 7, 2015

Record last verified: 2015-10

Locations

JP (9)