Clinical trial NCT00739973: Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
Official title: An 8-week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Amlodipine in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, Aliskiren, Amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 2694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* msDBP ≥ 90 mmHg and \< 110 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201)
* msDBP ≥ 95 mmHg and \< 110 mmHg at Visit 3 (Day 1 / randomization).
* All patients must have an absolute difference of ≤ 10 mmHg in their msDBP during the last 2 visits of the single-blind run-in period (Visit 2 and 3 or Visits 201 and 3).

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* Previous or current diagnosis of heart failure (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 malignancy within 5 years
* History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

Primary outcomes:
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline to end of study (Week 8)
Secondary outcomes:
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study
timeFrame: End of study (Week 8)
measure: Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response
timeFrame: End of study (Week 8)
measure: Percentage of Patients Achieving a Successful Systolic Blood Pressure Response
timeFrame: End of study (Week 8)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Investigative Site
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Canberra
country: Australia
facility: Invesigative Site
city: Toronto
country: Canada
facility: Investigative Site
city: Bogota
country: Colombia
facility: Investigative Site
city: Copenhagen
country: Denmark
facility: Investigative Site
city: Oslo
country: Finland
facility: Investigative Site
city: Athens
country: Greece
facility: Investigative Site
city: Rome
country: Italy
facility: Investigative Site
city: Mexico City
country: Mexico
facility: Investigative Site
city: Panama City
country: Panama
facility: Investigative Site
city: Lima
country: Peru
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Moscow
country: Russian Federation
facility: Investigative Site
city: Pretoria
country: South Africa
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Stockholm
country: Sweden
facility: Investigative Site
city: Taipei
country: Taiwan
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: