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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aliskiren 300 mg/Amlodipine 5 mg

Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.

Group Type EXPERIMENTAL

Aliskiren/Amlodipine 300/5 mg

Intervention Type DRUG

Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.

Placebo to Aliskiren

Intervention Type DRUG

Placebo to Aliskiren tablet taken orally once a day.

Aliskiren 300 mg/Amlodipine 10 mg

Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks.

Group Type EXPERIMENTAL

Aliskiren/Amlodipine 300/10 mg

Intervention Type DRUG

Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.

Placebo to Aliskiren

Intervention Type DRUG

Placebo to Aliskiren tablet taken orally once a day.

Aliskiren 300 mg

Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.

Group Type ACTIVE_COMPARATOR

Aliskiren 300 mg

Intervention Type DRUG

Aliskiren 300 mg tablet taken orally once a day with a glass of water.

Placebo to Aliskiren/Amlodipine

Intervention Type DRUG

Placebo to Aliskiren/Amlodipine taken orally once a day.

Interventions

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Aliskiren 300 mg

Aliskiren 300 mg tablet taken orally once a day with a glass of water.

Intervention Type DRUG

Aliskiren/Amlodipine 300/5 mg

Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.

Intervention Type DRUG

Aliskiren/Amlodipine 300/10 mg

Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.

Intervention Type DRUG

Placebo to Aliskiren

Placebo to Aliskiren tablet taken orally once a day.

Intervention Type DRUG

Placebo to Aliskiren/Amlodipine

Placebo to Aliskiren/Amlodipine taken orally once a day.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No