Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

NCT01876368 | Completed Phase 3 Results DMC

• 2 other identifiers: CLCZ696A23182013-001783-36
• Study Type: interventional
• Target: 376
• Locations: 7 countries
• Sites: 51

Brief Summary

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Conditions

Hypertension

Keywords

hypertension,; LCZ696,; olmesartan

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)

  Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.

  baseline, 8 weeks

Secondary Outcomes (10)

• Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)

  baseline, 8 weeks

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

  baseline, 8 weeks

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

  baseline, 8 weeks

• Change From Baseline in Office Pulse Pressure

  baseline, 8 weeks

• Number of Patients Achieving Successful Overall Blood Pressure Control

  8 weeks

Study Arms (2)

LCZ696 200 mg

EXPERIMENTAL

Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.

Drug: LCZ696; Drug: Placebo of LCZ696

Olmesartan 20 mg

ACTIVE COMPARATOR

Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.

Drug: Olmesartan; Drug: Placebo of Olmesartan

Interventions

LCZ696 DRUG

LCZ696 200 mg

Olmesartan DRUG

Olmesartan 20 mg

Placebo of LCZ696 DRUG

LCZ696 200 mg

Placebo of Olmesartan DRUG

Olmesartan 20 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 drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after washout epoch and after 4 weeks run-in epoch
• untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and \< 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and \< 180 mmHg after 4 weeks run-in epoch
• patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

You may not qualify if:

• Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
• History of angioedema, drug-related or otherwise
• 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 (PKD), drug-induced hypertension
• Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (51)

Novartis Investigative Site

Birmingham, Alabama, 35294-2041, United States

Location

Novartis Investigative Site

Fair Oaks, California, 95628, United States

Location

Novartis Investigative Site

Hawaiian Gardens, California, 90716, United States

Location

Novartis Investigative Site

Long Beach, California, 90806, United States

Location

Novartis Investigative Site

Los Angeles, California, 90057, United States

Location

Novartis Investigative Site

Orangevale, California, 95662, United States

Location

Novartis Investigative Site

Westlake Village, California, 91361, United States

Location

Novartis Investigative Site

Denver, Colorado, 80206, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30308, United States

Location

Novartis Investigative Site

Conyers, Georgia, 30094, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60607, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60610, United States

Location

Novartis Investigative Site

Topeka, Kansas, 66606, United States

Location

Novartis Investigative Site

Edina, Minnesota, 55435, United States

Location

Novartis Investigative Site

Belzoni, Mississippi, 39038, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39209, United States

Location

Novartis Investigative Site

New York, New York, 10708, United States

Location

Novartis Investigative Site

Cincinnati, Ohio, 45246, United States

Location

Novartis Investigative Site

Oregon City, Oregon, 97045, United States

Location

Novartis Investigative Site

Portland, Oregon, 97225, United States

Location

Novartis Investigative Site

Varnville, South Carolina, 29944, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23294, United States

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1120AAC, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires, C1429BWN, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1119ACN, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1430AAQ, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires F.D., C1425FVH, Argentina

Location

Novartis Investigative Site

Corrientes, Corrientes Province, W3400, Argentina

Location

Novartis Investigative Site

Posadas, Misiones Province, N3300AHX, Argentina

Location

Novartis Investigative Site

Guatemala City, Departamento de Guatemala, 01001, Guatemala

Location

Novartis Investigative Site

Guatemala City, Departamento de Guatemala, 01010, Guatemala

Location

Novartis Investigative Site

Quezon City, Manila, 1100, Philippines

Location

Novartis Investigative Site

Manila, National Capital Region, 1000, Philippines

Location

Novartis Investigative Site

Quezon City, 1100, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Manatí, 00674, Puerto Rico

Location

Novartis Investigative Site

Ponce, 00716, Puerto Rico

Location

Novartis Investigative Site

Ponce, 00717, Puerto Rico

Location

Novartis Investigative Site

Moscow, 101990, Russia

Location

Novartis Investigative Site

Moscow, 111539, Russia

Location

Novartis Investigative Site

Moscow, 117198, Russia

Location

Novartis Investigative Site

Moscow, 129301, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197110, Russia

Location

Novartis Investigative Site

Saint Petersburg, 199106, Russia

Location

Novartis Investigative Site

Saratov, 410012, Russia

Location

Novartis Investigative Site

Seville, Andalusia, 41009, Spain

Location

Novartis Investigative Site

Centelles, Catalonia, 08540, Spain

Location

Novartis Investigative Site

Hostalets de Balenya, Catalonia, 08550, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28046, Spain

Location

Novartis Investigative Site

Alzira, Valencia, 46600, Spain

Location

MeSH Terms

Conditions

Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination; olmesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

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: June 9, 2013
• First Posted: June 12, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 7, 2015
• Results First Posted: December 7, 2015

Record last verified: 2015-11

Locations

GU (2); PR (3); RU (7); ES (6); US (22); PH (4); AR (7)