Clinical trial NCT01663233: Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine
Official title: A Randomized, 8-week, Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 5 mg Monotherapy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Essential hypertension
High blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.


Eligibility criteria: Inclusion Criteria:

Patients must give written informed consent and have a diagnosis of hypertension:

Untreated patients must have an msSBP ≥ 150 mmHg and \< 180 mmHg at both Visit 1 and Visit 101. Pre-treated patients must have an msSBP ≥ 145 mmHg and \< 180 mmHg after wash out at Visit 101. All patients must have an office msSBP ≥ 145 mmHg and \< 180 mmHg at the completion of the 4-week run-in epoch (at the randomization visit (Visit 201).

Patients must successfully complete ABPM and pass technical requirements at Visit 201.

Exclusion Criteria:

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

History of myocardial infarction, coronary bypass surgery or PCI during the 12 months prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)
timeFrame: 8 weeks
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: 8 weeks
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: 8 weeks
measure: Change in Sitting Pulse Pressure (PP)
timeFrame: 8 weeks
measure: Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)
timeFrame: 8 weeks
measure: Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)
timeFrame: 8 weeks
measure: Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)
timeFrame: 8 weeks of treatment
measure: Number of Participants With Adverse Event
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kunitachi
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-Do
city: Koyang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Kyunggi
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Kuching
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
state: Manila
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Valenzuela City
country: Philippines
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
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: