Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
NCT ID: NCT01615198
Last Updated: 2015-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
588 participants
INTERVENTIONAL
2012-08-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LCZ696
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.
Placebo
Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
LCZ696
100 mg, 200 mg tablets
Olmesartan
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.
Olmesartan
10 mg, 20 mg, 40 mg capsules
Placebo
Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
Interventions
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Olmesartan
10 mg, 20 mg, 40 mg capsules
Placebo
Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
LCZ696
100 mg, 200 mg tablets
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Chongqing, Chongqing Municipality, China
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Changsha, Hunan, China
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Suzhou, Jiangsu, China
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Shenyang, Liaoning, China
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Xi’an, Shanxi, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Beijing, , 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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Hong Kong, Shatin, NT, Hong Kong
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Hong Kong, , Hong Kong
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Tōon, Ehime, Japan
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Chikushi-gun, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Kawasaki, Kanagawa, Japan
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Kyoto, Kyoto, Japan
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Kyōtanabe, Kyoto, Japan
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Osaka, Osaka, Japan
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Suita, Osaka, Japan
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Toyonaka, Osaka, Japan
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Fujimino, Saitama, Japan
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Hiki-Gun, Saitama, Japan
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Koshigaya, Saitama, Japan
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Saitama, Saitama, Japan
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Tokorozawa, Saitama, Japan
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Edogawa-ku, Tokyo, Japan
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Edogawa-ku, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Katsushika-ku, Tokyo, Japan
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Kiyose, Tokyo, Japan
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Kunitachi, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Shibuya-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Taitō City, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
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Quezon City, Manila, Philippines
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Manila, National Capital Region, Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Valenzuela, , Philippines
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Bucheon-si, Gyeonggi-do, South Korea
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Goyang-si, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Jeonju, Jeollabuk-do, South Korea
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Koyang, Kyunggi, South Korea
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Seoul, Seoul, South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Taichung, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taichung, Taiwan ROC, Taiwan
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Taipei, Taiwan, ROC, Taiwan
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
Countries
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Other Identifiers
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CLCZ696A2316
Identifier Type: -
Identifier Source: org_study_id
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