Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

NCT01593787 | Completed Phase 3 Results DMC

• 1 other identifier: CLCZ696A1304
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 13

Brief Summary

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

Conditions

Hypertension With Renal Dysfunction

Keywords

Hypertension; Renal dysfunction; LCZ696

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)

  Percentage of patients with total adverse events, serious adverse events and death were reported.

  8 weeks

Secondary Outcomes (7)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8

  baseline, 8 weeks

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8

  baseline, 8 weeks

• Percentage of Participants Achieving a Successful BP Control at Week 8

  8 weeks

• Percentage of Participants Achieving SBP Control at Week 8

  8 weeks

• Percentage of Participants Achieving DBP Control at Week 8

  8 weeks

Study Arms (3)

LCZ696 100 mg

EXPERIMENTAL

All participants were started on LCZ696 100 mg once daily on day 1.

Drug: LCZ696

LCZ696 200 mg

EXPERIMENTAL

All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP \<80 mmHg and msSBP \<130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.

Drug: LCZ696

LCZ696 400 mg

EXPERIMENTAL

All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP \<80 mmHg and msSBP \<130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.

Drug: LCZ696

Interventions

LCZ696 DRUG

100 mg, 200 mg, 400 mg tablets.

LCZ696 100 mg; LCZ696 200 mg; LCZ696 400 mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Sapporo, Hokkaido, 003-0026, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 003-0825, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 063-0842, Japan

Location

Novartis Investigative Site

Aira, Kagoshima-ken, 899-5431, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 210-0852, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 231-0023, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980-8574, Japan

Location

Novartis Investigative Site

Kurashiki, Okayama-ken, 701-0192, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 536-0008, Japan

Location

Novartis Investigative Site

Fujimino, Saitama, 356-0053, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0918, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-0032, Japan

Location

Related Publications (1)

• 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.

  PMID: 25693859 BACKGROUND

MeSH Terms

Conditions

Hypertension; Renal Insufficiency

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital 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: April 30, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-08

Locations

JP (13)