Clinical trial NCT00402103: An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
Official title: A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, amlodipine, HCTZ, blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).


Eligibility criteria: Inclusion Criteria:

* Outpatients 18 years of age or older
* Male or female patients are eligible
* For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
* For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Overall Percentage of Patients With Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54
measure: Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg
timeFrame: Baseline, Week 2, Week 10, Week 28 and Week 54
measure: Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, Week 2, Week 10, Week 28 and Week 54
Other outcomes:
Locations:
city: Santa Fe
country: United States
facility: Investigative Site
state: New Mexico
city: Investigative Site
country: Belgium
facility: Investigator Site
city: Investigative Center
country: Denmark
facility: Investigative Center
city: Investigative Site
country: Finland
facility: Investigative Site
city: Investigative Center
country: Germany
facility: Investigative Center
city: Investigative Site
country: Iceland
facility: Investigative Site
city: Investigative Site
country: India
facility: Investigative Site
city: Investigative Site
country: Switzerland
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W. Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin. 2009 Apr;25(4):951-9. doi: 10.1185/03007990902785845.