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

NCT ID: NCT00778921

Last Updated: 2016-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

847 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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Conditions

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Hypertension

Keywords

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Aliskiren Amlodipine Non-responder to Amlodipine

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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Amlodipine 10 mg

Amlodipine 10 mg

Group Type EXPERIMENTAL

Amlodipine 10 mg

Intervention Type DRUG

Amlodipine 10 mg

Aliskiren/Amlodipine 150/10 mg

Aliskiren/Amlodipine 150/10 mg

Group Type EXPERIMENTAL

Amlodipine 10 mg

Intervention Type DRUG

Amlodipine 10 mg

Aliskiren 150

Intervention Type DRUG

Aliskiren/Amlodipine 150/10 mg

Aliskiren/Amlodipine 300/10 mg

Aliskiren/Amlodipine 300/10 mg

Group Type EXPERIMENTAL

Amlodipine 10 mg

Intervention Type DRUG

Amlodipine 10 mg

Amlodipine 300

Intervention Type DRUG

Aliskiren/Amlodipine 300/10 mg

Interventions

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Amlodipine 10 mg

Amlodipine 10 mg

Intervention Type DRUG

Aliskiren 150

Aliskiren/Amlodipine 150/10 mg

Intervention Type DRUG

Amlodipine 300

Aliskiren/Amlodipine 300/10 mg

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 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 5 (randomization)

Exclusion Criteria

* Severe hypertension
* Pregnant or nursing (lactating) women
* Pre-menopausal women not taking accepted form of birth control
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
* History of cardiovascular conditions
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis

Role: STUDY_CHAIR

N

Locations

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Investigative Site

Buenos Aires, , Argentina

Site Status

Investigative Site

Berlin, , Germany

Site Status

Investigative Site

Oslo, , Norway

Site Status

Investigative Site

Warsaw, , Poland

Site Status

Investigative Site

Bratislava, , Slovakia

Site Status

Investigative Site

Stockholm, , Sweden

Site Status

Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Argentina Germany Norway Poland Slovakia Sweden Turkey (Türkiye)

References

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Pfeiffer D, Rennie N, Papst CC, Zhang J. Efficacy and tolerability of aliskiren/amlodipine single-pill combinations in patients who did not respond fully to amlodipine monotherapy yen. Curr Vasc Pharmacol. 2012 Nov;10(6):773-80. doi: 10.2174/157016112803520945.

Reference Type DERIVED
PMID: 22303911 (View on PubMed)

Other Identifiers

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CSPA100A2304

Identifier Type: -

Identifier Source: org_study_id