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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: LCZ696 (Drug); Olmesartan (Drug); Placebo of LCZ696 (Drug); Placebo of Olmesartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

Official title: A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Patients With Essential Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in mean sitting systolic blood pressure (msSBP) between LCZ696 200 mg versus olmesartan 20 mg

Secondary outcome:

Change from baseline in mean sitting systolic blood pressure between LCZ696 400 mg versus olmesartan 20 mg

Change from baseline in mean sitting diastolic blood pressure

Change from baseline in office pulse pressure

Change from baseline in mean 24-hour ambulatory blood pressure

Sub-group analysis for change from baseline in mean ambulatory systolic and diastolic blood pressure for nocturnal blood pressure dipper and non-dipper

Percentage of patients achieving successful blood pressure control

Number of patients with adverse events, serious adverse events, and death as assessment of safety and tolerability

Change from baseline in ambulatory pulse pressure

Percentage of responders

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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. Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Novartis Investigative Site, Beijing 100034, China

Novartis Investigative Site, Beijing 100029, China

Novartis Investigative Site, Beijing 100020, China

Novartis Investigative Site, Fuzhou 350001, China

Novartis Investigative Site, Shanghai 200032, China

Novartis Investigative Site, Shanghai 200025, China

Novartis Investigative Site, Shanghai 200031, China

Novartis Investigative Site, Tianjin 300142, China

Novartis Investigative Site, Hong Kong, Hong Kong

Novartis Investigative Site, Seoul 738-736, Korea, Republic of

Novartis Investigative Site, Seoul 152-703, Korea, Republic of

Novartis Investigative Site, Seoul 137-701, Korea, Republic of

Novartis Investigative Site, Quezon City 1100, Philippines

Novartis Investigative Site, Quezon City 1102, Philippines

Novartis Investigative Site, Singapore 169609, Singapore

Novartis Investigative Site, Kaohsiung 807, Taiwan

Novartis Investigative Site, Kaohsiung 82445, Taiwan

Novartis Investigative Site, New Taipei City 23561, Taiwan

Novartis Investigative Site, Taichung 40447, Taiwan

Novartis Investigative Site, Taipei County, Taiwan

Novartis Investigative Site, Taipei 10002, Taiwan

Novartis Investigative Site, Taipei 110, Taiwan

Novartis Investigative Site, Yun-Lin 640, Taiwan

Novartis Investigative Site, Bangkok 10700, Thailand

Novartis Investigative Site, Chiang Mai 50200, Thailand

Novartis Investigative Site, Khon Kaen 40002, Thailand

Novartis Investigative Site, Rajathevee 10400, Thailand

Novartis Investigative Site, Beijing, Beijing 100044, China

Novartis Investigative Site, Chongqing, Chongqing 400042, China

Novartis Investigative Site, Chongqing, Chongqing, China

Novartis Investigative Site, Fuzhou, Fujian, China

Novartis Investigative Site, Guangzhou, Guangdong 510030, China

Novartis Investigative Site, Guangzhou, Guangdong 510080, China

Novartis Investigative Site, Nanning, Guangxi 530021, China

Novartis Investigative Site, Shijiazhuang, Hebei 050000, China

Novartis Investigative Site, Harbin, Heilongjiang 150001, China

Novartis Investigative Site, Wuhan, Hubei 430030, China

Novartis Investigative Site, Changsha, Hunan 410003, China

Novartis Investigative Site, Nanjing, Jiangsu 210009, China

Novartis Investigative Site, Suzhou, Jiangsu 215006, China

Novartis Investigative Site, Nanchang, Jiangxi 330006, China

Novartis Investigative Site, Seoul, Korea 110 744, Korea, Republic of

Novartis Investigative Site, Koyang, Kyunggi 410-719, Korea, Republic of

Novartis Investigative Site, Shenyang, Liaoning 110016, China

Novartis Investigative Site, Shanghai, Shanghai 200072, China

Novartis Investigative Site, Shanghai, Shanghai 200120, China

Novartis Investigative Site, Xi'an, Shanxi 710004, China

Novartis Investigative Site, Xi'an, Shanxi 710061, China

Novartis Investigative Site, Tainan 704, Taiwan ROC, Taiwan

Novartis Investigative Site, Tianjin, Tianjin 300121, China

Novartis Investigative Site, Hangzhou, Zhejiang 310013, China

Additional Information

Starting date: April 2013
Last updated: September 11, 2014

Page last updated: August 20, 2015

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