Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

NCT01615198 | Completed Phase 3 Results

• 1 other identifier: CLCZ696A2316
• Study Type: interventional
• Target: 588
• Locations: 7 countries
• Sites: 79

Brief Summary

The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

Conditions

Essential Hypertension

Keywords

Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor

Outcome Measures

Primary Outcomes (1)

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

  Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

  Baseline, 10 weeks

Secondary Outcomes (11)

• Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

  Baseline, 10 weeks

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

  Baseline, 4 weeks, 14 weeks

• Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

  Baseline, 10 weeks

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

  Baseline, 10 weeks

• Change From Baseline in Mean Sitting Pulse Pressure

  Baseline, 4 weeks, 10 weeks, 14 weeks

Study Arms (2)

LCZ696

EXPERIMENTAL

Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.

Drug: Placebo; Drug: LCZ696

Olmesartan

ACTIVE COMPARATOR

Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.

Drug: Olmesartan; Drug: Placebo

Interventions

Olmesartan DRUG

10 mg, 20 mg, 40 mg capsules

Olmesartan

Placebo DRUG

Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule

LCZ696; Olmesartan

LCZ696 DRUG

100 mg, 200 mg tablets

LCZ696

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients must give written informed consent before any assessment is performed
• Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and \< 180 mmHg
• Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

You may not qualify if:

• Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
• Patients with history or evidence of a secondary form of hypertension
• Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
• History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
• Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
• Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
• Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
• Patients with a clinically significant valvular heart disease at the time of screening

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (79)

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400042, China

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Changsha, Hunan, 410003, China

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Suzhou, Jiangsu, 215006, China

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Shenyang, Liaoning, 110003, China

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Xi’an, Shanxi, 710061, China

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Hangzhou, Zhejiang, 310006, China

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Hangzhou, Zhejiang, 310013, China

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Beijing, 100020, China

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Shanghai, 200025, China

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Tianjin, 300142, China

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Hong Kong, Hong Kong, Hong Kong

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Hong Kong, Shatin, NT, Hong Kong

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Hong Kong, Hong Kong

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Tōon, Ehime, 791-0295, Japan

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Chikushi-gun, Fukuoka, 811-1244, Japan

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Fukuoka, Fukuoka, 810-0066, Japan

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Kitakyushu, Fukuoka, 807-0856, Japan

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Asahikawa, Hokkaido, 078-8214, Japan

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Sapporo, Hokkaido, 003-0026, Japan

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Sapporo, Hokkaido, 003-0825, Japan

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Sapporo, Hokkaido, 062-0053, Japan

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Sapporo, Hokkaido, 063-0842, Japan

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Kawasaki, Kanagawa, 210-0852, Japan

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Kyoto, Kyoto, 615-8125, Japan

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Kyōtanabe, Kyoto, 610-0361, Japan

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Osaka, Osaka, 560-0005, Japan

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Suita, Osaka, 565-0871, Japan

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Toyonaka, Osaka, 560-0082, Japan

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Fujimino, Saitama, 356-0053, Japan

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Hiki-Gun, Saitama, 355-0328, Japan

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Koshigaya, Saitama, 343-0826, Japan

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Saitama, Saitama, 337-0012, Japan

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Tokorozawa, Saitama, 359-1161, Japan

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Edogawa-ku, Tokyo, 133-0061, Japan

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Edogawa-ku, Tokyo, 134-0084, Japan

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Hachiōji, Tokyo, 192-0046, Japan

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Hachiōji, Tokyo, 192-0918, Japan

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Katsushika-ku, Tokyo, 124-0024, Japan

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Kiyose, Tokyo, 204-0021, Japan

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Kunitachi, Tokyo, 186-0001, Japan

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Meguro-ku, Tokyo, 152-0031, Japan

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Minato-ku, Tokyo, 105-7390, Japan

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Minato-ku, Tokyo, 108-0075, Japan

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Shibuya-ku, Tokyo, 150-0002, Japan

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Shinagawa-ku, Tokyo, 141-0032, Japan

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Tachikawa, Tokyo, 190-0013, Japan

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Taitō City, Tokyo, 111-0052, Japan

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Toshima-ku, Tokyo, 171-0021, Japan

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Quezon City, Manila, 1100, Philippines

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Manila, National Capital Region, 1000, Philippines

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Quezon City, 1100, Philippines

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Quezon City, 1102, Philippines

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Valenzuela, 1441, Philippines

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

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Goyang-si, Gyeonggi-do, 412-270, South Korea

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Seongnam-si, Gyeonggi-do, 463-707, South Korea

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Jeonju, Jeollabuk-do, 561-712, South Korea

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Koyang, Kyunggi, 410-719, South Korea

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Seoul, Seoul, 150-713, South Korea

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Daegu, 700-712, South Korea

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Daejeon, 302-241, South Korea

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Incheon, 22332, South Korea

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Incheon, 403-720, South Korea

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Seoul, 100-380, South Korea

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Seoul, 134-727, South Korea

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Seoul, 135-720, South Korea

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Seoul, 150-950, South Korea

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Seoul, 152-703, South Korea

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Taichung, Taiwan, 40447, Taiwan

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Taipei, Taiwan, 10002, Taiwan

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Taipei, Taiwan, 114, Taiwan

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Taichung, Taiwan ROC, 40201, Taiwan

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Taipei, Taiwan, ROC, 112, Taiwan

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Changhua, 500, Taiwan

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Kaohsiung City, 807, Taiwan

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Taipei, Taiwan

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

olmesartan; sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 23, 2015
• Results First Posted: August 18, 2015

Record last verified: 2015-10

Locations

HK (3); CN (10); KR (15); TH (3); PH (5); TW (8); JP (35)