Clinical trial NCT00778921: Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine 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 (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Aliskiren
Amlodipine
Non-responder to Amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 847
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 with hypertension not adequately controlled with amlodipine 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 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 5 (randomization)

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing (lactating) women
* Pre-menopausal women not taking accepted form of birth control
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
* History of cardiovascular conditions
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study
timeFrame: Baseline and Week 8
measure: Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group
timeFrame: 8 weeks
measure: Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Berlin
country: Germany
facility: Investigative Site
city: Oslo
country: Norway
facility: Investigative Site
city: Warsaw
country: Poland
facility: Investigative Site
city: Bratislava
country: Slovakia
facility: Investigative Site
city: Stockholm
country: Sweden
facility: Investigative Site
city: Ankara
country: Turkey
facility: Investigative Site
Study officials:
affiliation: N
name: Novartis
role: STUDY_CHAIR
References:
citation: Pfeiffer D, Rennie N, Papst CC, Zhang J. Efficacy and tolerability of aliskiren/amlodipine single-pill combinations in patients who did not respond fully to amlodipine monotherapy yen. Curr Vasc Pharmacol. 2012 Nov;10(6):773-80. doi: 10.2174/157016112803520945.