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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00739973




Registration number
NCT00739973
Ethics application status
Date submitted
20/08/2008
Date registered
22/08/2008
Date last updated
6/06/2011

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
Scientific 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
Secondary ID [1] 0 0
CSPA100A2305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Aliskiren 150 mg tablet
Treatment: Drugs - Aliskiren 300 mg tablet
Treatment: Drugs - Amlodipine 5 mg capsule
Treatment: Drugs - Amlodipine 10 mg capsule
Treatment: Drugs - Aliskiren/amlodipine 150/5 mg tablet
Treatment: Drugs - Aliskiren/amlodipine 150/10 mg tablet
Treatment: Drugs - Aliskiren/amlodipine 300/5 mg tablet
Treatment: Drugs - Aliskiren/amlodipine 300/10 mg tablet

Placebo Comparator: Placebo - Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 5 of the 5 pills taken were placebos.

Experimental: Aliskiren 150 mg tablet - Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Experimental: Aliskiren 300 mg tablet - Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Experimental: Amlodipine 5 mg capsule - Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Experimental: Amlodipine 10 mg capsule - Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg

Experimental: Aliskiren/amlodipine 150/5 mg tablet - Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Experimental: Aliskiren/amlodipine 150/10 mg tablet - 150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Experimental: Aliskiren/amlodipine 300/5 mg tablet - Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.

Experimental: Aliskiren/amlodipine 300/10 mg tablet - 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.


Treatment: Drugs: Placebo


Treatment: Drugs: Aliskiren 150 mg tablet


Treatment: Drugs: Aliskiren 300 mg tablet


Treatment: Drugs: Amlodipine 5 mg capsule


Treatment: Drugs: Amlodipine 10 mg capsule


Treatment: Drugs: Aliskiren/amlodipine 150/5 mg tablet


Treatment: Drugs: Aliskiren/amlodipine 150/10 mg tablet


Treatment: Drugs: Aliskiren/amlodipine 300/5 mg tablet


Treatment: Drugs: Aliskiren/amlodipine 300/10 mg tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [1] 0 0
Baseline to end of study (Week 8)
Primary outcome [2] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [2] 0 0
Baseline to end of study (Week 8)
Primary outcome [3] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [3] 0 0
Baseline to end of study (Week 8)
Primary outcome [4] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [4] 0 0
Baseline to end of study (Week 8)
Primary outcome [5] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [5] 0 0
Baseline to end of study (Week 8)
Primary outcome [6] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [6] 0 0
Baseline to end of study (Week 8)
Primary outcome [7] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [7] 0 0
Baseline to end of study (Week 8)
Primary outcome [8] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [8] 0 0
Baseline to end of study (Week 8)
Primary outcome [9] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [9] 0 0
Baseline to end of study (Week 8)
Primary outcome [10] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [10] 0 0
Baseline to end of study (Week 8)
Primary outcome [11] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [11] 0 0
Baseline to end of study (Week 8)
Primary outcome [12] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Timepoint [12] 0 0
Baseline to end of study (Week 8)
Secondary outcome [1] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [1] 0 0
Baseline to end of study (Week 8)
Secondary outcome [2] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [2] 0 0
Baseline to end of study (Week 8)
Secondary outcome [3] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [3] 0 0
Baseline to end of study (Week 8)
Secondary outcome [4] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)
Timepoint [4] 0 0
Baseline to end of study (Week 8)
Secondary outcome [5] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [5] 0 0
Baseline to end of study (Week 8)
Secondary outcome [6] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [6] 0 0
Baseline to end of study (Week 8)
Secondary outcome [7] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [7] 0 0
Baseline to end of study (Week 8)
Secondary outcome [8] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [8] 0 0
Baseline to end of study (Week 8)
Secondary outcome [9] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [9] 0 0
Baseline to end of study (Week 8)
Secondary outcome [10] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [10] 0 0
Baseline to end of study (Week 8)
Secondary outcome [11] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [11] 0 0
Baseline to end of study (Week 8)
Secondary outcome [12] 0 0
Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)
Timepoint [12] 0 0
Baseline to end of study (Week 8)
Secondary outcome [13] 0 0
Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study
Timepoint [13] 0 0
End of study (Week 8)
Secondary outcome [14] 0 0
Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response
Timepoint [14] 0 0
End of study (Week 8)
Secondary outcome [15] 0 0
Percentage of Patients Achieving a Successful Systolic Blood Pressure Response
Timepoint [15] 0 0
End of study (Week 8)

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
2694
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Invesigative Site - Canberra
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Canada
State/province [3] 0 0
Toronto
Country [4] 0 0
Colombia
State/province [4] 0 0
Bogota
Country [5] 0 0
Denmark
State/province [5] 0 0
Copenhagen
Country [6] 0 0
Finland
State/province [6] 0 0
Oslo
Country [7] 0 0
Greece
State/province [7] 0 0
Athens
Country [8] 0 0
Italy
State/province [8] 0 0
Rome
Country [9] 0 0
Mexico
State/province [9] 0 0
Mexico City
Country [10] 0 0
Panama
State/province [10] 0 0
Panama City
Country [11] 0 0
Peru
State/province [11] 0 0
Lima
Country [12] 0 0
Romania
State/province [12] 0 0
Bucharest
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Moscow
Country [14] 0 0
South Africa
State/province [14] 0 0
Pretoria
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Sweden
State/province [16] 0 0
Stockholm
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in
combination with amlodipine in patients with essential hypertension.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00739973
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Novartis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries