A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

NCT01256411 | Completed Phase 2 Results

• 1 other identifier: CLCZ696A2219E1
• Study Type: interventional
• Target: 341
• Locations: 5 countries
• Sites: 33

Brief Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Conditions

Essential Hypertension

Keywords

hypertension; blood pressure; LCZ696; dual-acting; neprilysin; nep inhibitor; vasopeptidase; angiotensin receptor; angiotensin receptor neprilysin inhibitor (ARNi)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)

  Participants were monitored throughout the study for adverse events, serious adverse events and deaths.

  Baseline to 12 months

Secondary Outcomes (4)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)

  Baseline, 12 months

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)

  Baseline, 12 months

• Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)

  Baseline to 12 months

• Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)

  Baseline to 12 months

Study Arms (1)

LCZ696

EXPERIMENTAL

Drug: LCZ696; Drug: Amlodipine; Drug: Hydrochlorothiazide (HCTZ)

Interventions

LCZ696 DRUG

Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.

LCZ696

Amlodipine DRUG

Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

LCZ696

Hydrochlorothiazide (HCTZ) DRUG

Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

LCZ696

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
• Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

You may not qualify if:

• Patients who did not complete CLCZ696A2219.
• Presence of significant protocol violation in CLCZ696A2219.
• Patients who are deemed to be unable to comply with the protocol by the investigator.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (33)

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400042, China

Location

Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310006, China

Location

Novartis Investigative Site

Beijing, 100044, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Tianjin, 300142, China

Location

Novartis Investigative Site

Yokohama, Kanagawa, 231-0023, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-0031, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 100-0005, Japan

Location

Novartis Investigative Site

Kiyose, Tokyo, 204-0021, Japan

Location

Novartis Investigative Site

Kunitachi, Tokyo, 186-0001, 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

Shinagawa-ku, Tokyo, 141-0032, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-0053, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-0063, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0021, Japan

Location

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, 424-717, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 137-701, South Korea

Location

Novartis Investigative Site

Koyang, Kyunggi, 410-719, South Korea

Location

Novartis Investigative Site

Daegu, 705-703, South Korea

Location

Novartis Investigative Site

Seoul, 150-950, South Korea

Location

Novartis Investigative Site

Seoul, 152-703, South Korea

Location

Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 10449, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 114, Taiwan

Location

Novartis Investigative Site

Changhua, 500, Taiwan

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 21, 2015
• Results First Posted: October 21, 2015

Record last verified: 2015-09

Locations

KR (6); JP (13); TW (5); TH (3); CN (6)