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

NCT01785472 | Completed Phase 3 Results DMC

• 1 other identifier: CLCZ696A2315
• Study Type: interventional
• Target: 1,438
• Locations: 7 countries
• Sites: 50

Brief Summary

This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian 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) Between LCZ696 200 mg Versus Olmesartan 20 mg

  Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.

  baseline, 8 weeks

Secondary Outcomes (12)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg

  baseline, 8 weeks

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg

  baseline, 8 weeks

• Change From Baseline in Office Pulse Pressure (msPP)

  baseline, 8 weeks

• Change From Baseline in Mean 24-hour Ambulatory Blood Pressure

  baseline, 8 weeks

• Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.

  baseline, 8 weeks

Study Arms (3)

LCZ696 200 mg

EXPERIMENTAL

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.

Drug: LCZ696; Drug: Placebo of LCZ696; Drug: Placebo of Olmesartan

LCZ696 400 mg

EXPERIMENTAL

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.

Drug: LCZ696; Drug: Placebo of LCZ696; Drug: Placebo of Olmesartan

Olmesartan 20 mg

ACTIVE COMPARATOR

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

Drug: Olmesartan; Drug: Placebo of LCZ696

Interventions

LCZ696 DRUG

LCZ696 200 mg tablet

LCZ696 200 mg; LCZ696 400 mg

Olmesartan DRUG

Olmesartan 20 mg capsule

Olmesartan 20 mg

Placebo of LCZ696 DRUG

Placebo tablet of LCZ696 200 mg once daily

LCZ696 200 mg; LCZ696 400 mg; Olmesartan 20 mg

Placebo of Olmesartan DRUG

Placebo capsule of olmesartan 20 mg once daily

LCZ696 200 mg; LCZ696 400 mg

Eligibility Criteria

• Age: 18 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (50)

Novartis Investigative Site

Beijing, Beijing Municipality, 100044, China

Location

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400010, China

Location

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400042, China

Location

Novartis Investigative Site

Fuzhou, Fujian, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

Location

Novartis Investigative Site

Nanning, Guangxi, 530021, China

Location

Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150001, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Changsha, Hunan, 410003, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210009, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215006, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110016, China

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200072, China

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200120, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710004, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710061, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300121, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310013, China

Location

Novartis Investigative Site

Beijing, 100020, China

Location

Novartis Investigative Site

Beijing, 100029, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Fuzhou, 350001, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Shanghai, 200031, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Tianjin, 300142, China

Location

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Quezon City, Manila, 1100, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Singapore, Singapore, 169609, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 03080, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06591, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 08308, South Korea

Location

Novartis Investigative Site

Koyang, Kyunggi, 410-719, South Korea

Location

Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

Location

Novartis Investigative Site

Taipei County, Taiwan, 22060, Taiwan

Location

Novartis Investigative Site

Tainan, Taiwan ROC, 70403, Taiwan

Location

Novartis Investigative Site

Douliu, 640, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 807, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 82445, Taiwan

Location

Novartis Investigative Site

New Taipei City, 23561, Taiwan

Location

Novartis Investigative Site

Taipei, 110, Taiwan

Location

Novartis Investigative Site

Rajathevee, Thailand, 10400, Thailand

Location

Novartis Investigative Site

Khon Kaen, THA, 40002, Thailand

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

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

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 29, 2016
• Results First Posted: September 4, 2015

Record last verified: 2016-11

Locations

HK (1); PH (2); KR (5); TW (9); TH (4); SG (1); CN (28)