Clinical trial NCT01692301: Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 454
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study examined 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).


Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Central Pulse (CPP) Pressure
timeFrame: Baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean Pulse Wave Velocity (PWV)
timeFrame: baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks
timeFrame: baseline, 52 weeks
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean Sitting Pulse Pressure (msPP)
timeFrame: baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean Arterial Pressure (MAP)
timeFrame: baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)
timeFrame: Baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)
timeFrame: Baseline, 12 weeks, and 52 weeks
measure: Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)
timeFrame: Baseline, 12 weeks, and 52 weeks
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Belzoni
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Novartis Investigative Site
state: Texas
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: Texas
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ramos Mejia
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Treviglio
country: Italy
facility: Novartis Investigative Site
state: BG
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: San Daniele Del Friuli
country: Italy
facility: Novartis Investigative Site
state: UD
city: Shimotsuke-city
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Bucheon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Jerez de La Frontera
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Puerto de Sagunto
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan, ROC
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Williams B, Cockcroft JR, Kario K, Zappe DH, Cardenas P, Hester A, Brunel P, Zhang J. Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study. BMJ Open. 2014 Feb 4;4(2):e004254. doi: 10.1136/bmjopen-2013-004254.