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

NCT ID: NCT01593787

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-03-31

Brief Summary

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

Conditions

Hypertension With Renal Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LCZ696 100 mg

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

Group Type: EXPERIMENTAL

LCZ696

Intervention Type: DRUG

100 mg, 200 mg, 400 mg tablets.

LCZ696 200 mg

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.

Group Type: EXPERIMENTAL

LCZ696

Intervention Type: DRUG

100 mg, 200 mg, 400 mg tablets.

LCZ696 400 mg

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.

Group Type: EXPERIMENTAL

LCZ696

Intervention Type: DRUG

100 mg, 200 mg, 400 mg tablets.

Interventions

LCZ696

100 mg, 200 mg, 400 mg tablets.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Aira, Kagoshima-ken, Japan

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Kurashiki, Okayama-ken, Japan

Novartis Investigative Site

Osaka, Osaka, Japan

Novartis Investigative Site

Fujimino, Saitama, Japan

Novartis Investigative Site

Hachiōji, Tokyo, Japan

Novartis Investigative Site

Minato-ku, Tokyo, Japan

Novartis Investigative Site

Shinagawa-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 25693859 (View on PubMed)

Other Identifiers

CLCZ696A1304

Identifier Type: -

Identifier Source: org_study_id