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

NCT ID: NCT01785472

Last Updated: 2016-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-08-31

Brief Summary

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This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension

Detailed Description

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Conditions

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Essential Hypertension

Keywords

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Essential hypertension LCZ696

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LCZ696 200 mg

Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

LCZ696 200 mg tablet

Placebo of LCZ696

Intervention Type DRUG

Placebo tablet of LCZ696 200 mg once daily

Placebo of Olmesartan

Intervention Type DRUG

Placebo capsule of olmesartan 20 mg once daily

LCZ696 400 mg

Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

LCZ696 200 mg tablet

Placebo of LCZ696

Intervention Type DRUG

Placebo tablet of LCZ696 200 mg once daily

Placebo of Olmesartan

Intervention Type DRUG

Placebo capsule of olmesartan 20 mg once daily

Olmesartan 20 mg

Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.

Group Type ACTIVE_COMPARATOR

Olmesartan

Intervention Type DRUG

Olmesartan 20 mg capsule

Placebo of LCZ696

Intervention Type DRUG

Placebo tablet of LCZ696 200 mg once daily

Interventions

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LCZ696

LCZ696 200 mg tablet

Intervention Type DRUG

Olmesartan

Olmesartan 20 mg capsule

Intervention Type DRUG

Placebo of LCZ696

Placebo tablet of LCZ696 200 mg once daily

Intervention Type DRUG

Placebo of Olmesartan

Placebo capsule of olmesartan 20 mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
* Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and \<180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg \<180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).
* Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and \<180 mmHg at both Visit 1 and Visit 201.
* Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.

Exclusion Criteria

* Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).
* History of angioedema, drug-related or otherwise, as reported by the patient.
* History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status

Novartis Investigative Site

Chongqing, Chongqing Municipality, China

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Chongqing, Chongqing Municipality, China

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Novartis Investigative Site

Fuzhou, Fujian, China

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Guangzhou, Guangdong, China

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Nanning, Guangxi, China

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Shijiazhuang, Hebei, China

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Harbin, Heilongjiang, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Nanjing, Jiangsu, China

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Suzhou, Jiangsu, China

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Nanchang, Jiangxi, China

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Shenyang, Liaoning, China

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Shanghai, Shanghai Municipality, China

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Shanghai, Shanghai Municipality, China

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Xi’an, Shanxi, China

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Xi’an, Shanxi, China

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Tianjin, Tianjin Municipality, China

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Hangzhou, Zhejiang, China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Fuzhou, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Tianjin, , China

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Hong Kong, Hong Kong, Hong Kong

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Quezon City, Manila, Philippines

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Quezon City, , Philippines

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Singapore, Singapore, Singapore

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Koyang, Kyunggi, South Korea

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Taichung, Taiwan, Taiwan

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Taipei, Taiwan, Taiwan

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Taipei County, Taiwan, Taiwan

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Tainan City, Taiwan ROC, Taiwan

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Douliu, , Taiwan

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Kaohsiung City, , Taiwan

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Novartis Investigative Site

Kaohsiung City, , Taiwan

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Novartis Investigative Site

New Taipei City, , Taiwan

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Taipei, , Taiwan

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Rajathevee, Thailand, Thailand

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Novartis Investigative Site

Khon Kaen, THA, Thailand

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Novartis Investigative Site

Bangkok, , Thailand

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Novartis Investigative Site

Chiang Mai, , Thailand

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Countries

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China Hong Kong Philippines Singapore South Korea Taiwan Thailand

Other Identifiers

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CLCZ696A2315

Identifier Type: OTHER

Identifier Source: secondary_id

CLCZ696A2315

Identifier Type: -

Identifier Source: org_study_id