Clinical trial NCT00777946: Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
Official title: A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Aliskiren, Amlodipine, Non-responder to aliskiren
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 818
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 the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP) ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2
* Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1 must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 2
* All patients must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 4

Exclusion Criteria:

* Severe 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

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, End of Study (Week 8)
Secondary outcomes:
measure: Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline, End of Study (Week 8)
measure: Number of Participants With Serious Adverse Events and Adverse Events
timeFrame: 8 weeks
measure: Percentage of Participants Achieving Blood Pressure Control
timeFrame: 8 weeks
measure: Percentage of Participants Achieving a Diastolic Blood Pressure Response
timeFrame: 8 weeks
measure: Percentage of Participants Achieving a Systolic Blood Pressure Response
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Estonia
country: Estonia
facility: Investigative site
city: France
country: France
facility: Investigative site
city: Iceland
country: Iceland
facility: Investigative Site
city: India
country: India
facility: Investigative Site
city: Italy
country: Italy
facility: Investigative site
city: Republic of Korea
country: Korea, Republic of
facility: Investigative Site
city: Lithuania
country: Lithuania
facility: Investigative Site
city: Spain
country: Spain
facility: Investigative Site
city: Venezuela
country: Venezuela
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55. doi: 10.2174/157016112803520765.