Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension
NCT ID: NCT01599104
Last Updated: 2015-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1161 participants
INTERVENTIONAL
2012-06-30
2013-04-30
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
QUADRUPLE
Study Groups
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LCZ696 200 mg
LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks
LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
Placebo
Placebo to LCZ696 or Olmesartan
LCZ696 400 mg
LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks
LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
Placebo
Placebo to LCZ696 or Olmesartan
Olmesartan 20 mg
Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks
Olmesartan
Olmesartan 20 mg capsule one daily
Placebo
Placebo to LCZ696 or Olmesartan
Interventions
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LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
Olmesartan
Olmesartan 20 mg capsule one daily
Placebo
Placebo to LCZ696 or Olmesartan
Eligibility Criteria
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Inclusion Criteria
* 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 proceeding 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
* 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.
20 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
Kamogawa, Chiba, Japan
Novartis Investigative Site
Chikushi-gun, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Asahikawa, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
Novartis Investigative Site
Amagasaki, Hyōgo, Japan
Novartis Investigative Site
Hitachi, Ibaraki, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
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Kyoto, Kyoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
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Kyōtanabe, Kyoto, Japan
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Kashihara, Nara, Japan
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Ibadraki, Osaka, Japan
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Osaka, Osaka, Japan
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Osaka, Osaka, Japan
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Osaka, Osaka, Japan
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Osaka, Osaka, Japan
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Toyonaka, Osaka, Japan
Novartis Investigative Site
Ageo, Saitama, Japan
Novartis Investigative Site
Fujimino, Saitama, Japan
Novartis Investigative Site
Hiki-Gun, Saitama, Japan
Novartis Investigative Site
Koshigaya, Saitama, Japan
Novartis Investigative Site
Niiza, Saitama, Japan
Novartis Investigative Site
Saitama, Saitama, Japan
Novartis Investigative Site
Sakado, Saitama, Japan
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Tokorozawa, Saitama, Japan
Novartis Investigative Site
Shimotsuke, Tochigi, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Chiyoda-ku, Tokyo, 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
Novartis Investigative Site
Katsushika-ku, Tokyo, Japan
Novartis Investigative Site
Kiyose, Tokyo, Japan
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Kunitachi, Tokyo, Japan
Novartis Investigative Site
Meguro-ku, Tokyo, Japan
Novartis Investigative Site
Minato-ku, Tokyo, Japan
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Minato-ku, Tokyo, Japan
Novartis Investigative Site
Nerima-ku, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Shibuya-ku, Tokyo, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Tachikawa, Tokyo, Japan
Novartis Investigative Site
Taitō City, Tokyo, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, Japan
Countries
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References
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Kario K, Rakugi H, Yarimizu D, Morita Y, Eguchi S, Iekushi K. Twenty-Four-Hour Blood Pressure-Lowering Efficacy of Sacubitril/Valsartan Versus Olmesartan in Japanese Patients With Essential Hypertension Based on Nocturnal Blood Pressure Dipping Status: A Post Hoc Analysis of Data From a Randomized, Double-Blind Multicenter Study. J Am Heart Assoc. 2023 Apr 18;12(8):e027612. doi: 10.1161/JAHA.122.027612. Epub 2023 Apr 7.
Other Identifiers
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CLCZ696A1306
Identifier Type: -
Identifier Source: org_study_id
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