Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

Hypertension Clinical Trial

Official title:

A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692301
• Other study ID #: CLCZ696A2216
• Secondary ID: 2012-002899-14
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2012
• Last updated: October 5, 2015
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of HealthBrazil: Ministry of HealthColombia: National Institutes of HealthFrance: Ministry of HealthGermany: Ministry of HealthGreece: Ministry of Health and WelfareItaly: Ministry of HealthJapan: Ministry of Health, Labor and WelfareKorea: Food and Drug AdministrationRussia: Pharmacological Committee, Ministry of HealthSpain: Ministry of HealthTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

To examine the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Male and female patients = 60 years of age.

2. Patients with essential hypertension, untreated or currently taking antihypertensive therapy.

3. Untreated patients must have an office msSBP =150 mmHg and <180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.

4. Treated patients must have an office msSBP =140 mmHg and <180 mmHg at Visit 102 (or Visit 103) and msSBP =150 mmHg and <180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.

5. All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.

6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.

Exclusion Criteria:

1. Malignant or severe hypertension (grade 3 of WHO classification; msDBP =110 mmHg and/or msSBP = 180 mmHg)

2. History of angioedema, drug-related or otherwise.

3. 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.

4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.

5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.

6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• LCZ696
Investigational drug
• Olmesartan
Comparator Drug
• LCZ696 matching placebo
LCZ696 Matching Placebo tablet
• Olmesartan matching placebo
Olmesartan matching placebo capsule
• amlodipine
amlodipine 2.5 mg or 5 mg tablets
• hydrochlorothiazide
hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ramos Mejia	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Barranquilla
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Nuernberg
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki	GR
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	San Daniele Del Friuli	UD
Italy	Novartis Investigative Site	Treviglio	BG
Japan	Novartis Investigative Site	Shimotsuke-city	Tochigi
Korea, Republic of	Novartis Investigative Site	Bucheon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Sankt-Peterburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Centelles	Cataluña
Spain	Novartis Investigative Site	Jerez de La Frontera	Andalucia
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Puerto de Sagunto	Comunidad Valenciana
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Terrassa	Cataluña
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei	Taiwan, ROC
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Belzoni	Mississippi
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Lake Jackson	Texas
United States	Novartis Investigative Site	Pasadena	Texas
United States	Novartis Investigative Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean central aortic systolic blood pressure at 12 weeks		baseline, 12 weeks	No
Secondary	Change from baseline in mean central pulse pressure		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean aortic pulse wave velocity		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean central aortic systolic blood pressure at 52 weeks		baseline, 52 weeks	No
Secondary	Change from baseline in mean sitting systolic blood pressure		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean sitting diastolic blood pressure		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean sitting pulse pressure		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean arterial pressure		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean 24-hour systolic blood pressure		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean 24-hour diastolic blood pressure		baseline, 12 weeks, and 52 weeks	No
Secondary	Change from baseline in mean 24-hour ambulatory pulse pressure		baseline, 12 weeks, and 52 weeks	No