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

NCT01599104 | Completed Phase 3 Results DMC

• 1 other identifier: CLCZ696A1306
• Study Type: interventional
• Target: 1,161
• Locations: 1 country
• Sites: 61

Brief Summary

This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension

Conditions

Essential Hypertension

Keywords

Essential hypertension; LCZ696

Outcome Measures

Primary Outcomes (1)

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

  Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.

  Baseline, 8 weeks

Secondary Outcomes (10)

• Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8

  Baseline, 8 weeks

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

  Baseline, 8 weeks

• Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8

  8 weeks

• Percentage of Participants Achieving a Successful msSBP Response

  8 weeks

• Percentage of Participants Achieving a Successful msDBP Response

  8 weeks

Study Arms (3)

LCZ696 200 mg

EXPERIMENTAL

LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks

Drug: LCZ696; Drug: Placebo

LCZ696 400 mg

EXPERIMENTAL

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

Drug: LCZ696; Drug: Placebo

Olmesartan 20 mg

ACTIVE COMPARATOR

Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks

Drug: Olmesartan; Drug: Placebo

Interventions

LCZ696 DRUG

200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily

LCZ696 200 mg; LCZ696 400 mg

Olmesartan DRUG

Olmesartan 20 mg capsule one daily

Olmesartan 20 mg

Placebo DRUG

Placebo to LCZ696 or Olmesartan

LCZ696 200 mg; LCZ696 400 mg; Olmesartan 20 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (61)

Novartis Investigative Site

Kamogawa, Chiba, 296-8602, Japan

Location

Novartis Investigative Site

Chikushi-gun, Fukuoka, 811-1244, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 810-0014, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 810-0066, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 814-0032, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 800-0225, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-0856, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 078-8214, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 003-0026, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 003-0825, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 006-0811, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 062-0053, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 063-0842, Japan

Location

Novartis Investigative Site

Amagasaki, Hyōgo, 660-0814, Japan

Location

Novartis Investigative Site

Hitachi, Ibaraki, 317-0077, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 210-0852, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 231-0023, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236-0004, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 615-0035, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 615-8125, Japan

Location

Novartis Investigative Site

Kyōtanabe, Kyoto, 610-0361, Japan

Location

Novartis Investigative Site

Kashihara, Nara, 634-8522, Japan

Location

Novartis Investigative Site

Ibadraki, Osaka, 567-0876, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 536-0008, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 547-0013, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 550-0013, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 560-0005, Japan

Location

Novartis Investigative Site

Toyonaka, Osaka, 560-0082, Japan

Location

Novartis Investigative Site

Ageo, Saitama, 362-8588, Japan

Location

Novartis Investigative Site

Fujimino, Saitama, 356-0053, Japan

Location

Novartis Investigative Site

Hiki-Gun, Saitama, 355-0328, Japan

Location

Novartis Investigative Site

Koshigaya, Saitama, 343-0826, Japan

Location

Novartis Investigative Site

Niiza, Saitama, 352-0014, Japan

Location

Novartis Investigative Site

Saitama, Saitama, 337-0012, Japan

Location

Novartis Investigative Site

Sakado, Saitama, 350-0202, Japan

Location

Novartis Investigative Site

Tokorozawa, Saitama, 359-1161, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-0031, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 100-0005, Japan

Location

Novartis Investigative Site

Edogawa-ku, Tokyo, 133-0061, Japan

Location

Novartis Investigative Site

Edogawa-ku, Tokyo, 134-0084, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0046, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0918, Japan

Location

Novartis Investigative Site

Katsushika-ku, Tokyo, 124-0024, Japan

Location

Novartis Investigative Site

Kiyose, Tokyo, 204-0021, Japan

Location

Novartis Investigative Site

Kunitachi, Tokyo, 186-0001, Japan

Location

Novartis Investigative Site

Meguro-ku, Tokyo, 152-0031, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-7390, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Novartis Investigative Site

Nerima-ku, Tokyo, 177-0051, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 143-0023, Japan

Location

Novartis Investigative Site

Shibuya-ku, Tokyo, 150-0002, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-0032, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-0053, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-0063, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Novartis Investigative Site

Tachikawa, Tokyo, 190-0013, Japan

Location

Novartis Investigative Site

Taitō City, Tokyo, 111-0052, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0021, Japan

Location

Related Publications (1)

• 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.

  PMID: 37026551 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination; olmesartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

+1 (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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2012
• First Posted: May 15, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 16, 2015
• Results First Posted: August 6, 2015

Record last verified: 2015-09

Locations

JP (61)