Clinical trial NCT00841672: Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
Official title: An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Hypertension
Keywords: Hypertension
systolic blood pressure
cardiovascular disease
aliskiren
amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 485
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 compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Outpatients ≥ 18 years of age
* Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and \< 200 mmHg at Visit 2

Exclusion Criteria:

* Mild to moderate hypertension
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
* History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
* Patients on a combination of 3 or more antihypertensive medications

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
Secondary outcomes:
measure: Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Systolic Blood Pressure Response
timeFrame: Baseline to end of study (Week 8)
measure: Diastolic Blood Pressure Response
timeFrame: Baseline to end of study (Week 8)
measure: Blood Pressure Control
timeFrame: End of study (Week 8)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigative Site
city: Manilla
country: Philippines
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Moscow
country: Russian Federation
facility: Investigative Site
city: Singapore
country: Singapore
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: