Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00777946
• Date of registration: 20/10/2008
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone
• Scientific 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
• Date of first enrolment: October 2008
• Target sample size: 818
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00777946
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Estonia, France, Iceland, India, Italy, Korea, Republic of, Lithuania, South Africa, Spain, Venezuela

Contacts

• Name: Novartis
• Affiliation: Novartis

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Aliskiren/Amlodipine 300/10 mg

Drug: Placebo to Aliskiren

Drug: Aliskiren 300 mg

Drug: Aliskiren/Amlodipine 300/5 mg

Drug: Placebo to Aliskiren/Amlodipine

Primary Outcome(s)

Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) [Time Frame: Baseline, End of Study (Week 8)]

Secondary Outcome(s)

Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) [Time Frame: Baseline, End of Study (Week 8)]

Percentage of Participants Achieving a Diastolic Blood Pressure Response [Time Frame: 8 weeks]

Number of Participants With Serious Adverse Events and Adverse Events [Time Frame: 8 weeks]

Percentage of Participants Achieving a Systolic Blood Pressure Response [Time Frame: 8 weeks]

Percentage of Participants Achieving Blood Pressure Control [Time Frame: 8 weeks]

Secondary ID(s)

CSPA100A2303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00777946