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Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine

NCT ID: NCT01113047

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.

Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.

Detailed Description

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Conditions

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Essential Hypertension

Keywords

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Hypertension Aliskiren Amlodipine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non responder Olmesartan/Amlodipine

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Group Type EXPERIMENTAL

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Intervention Type DRUG

Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Interventions

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Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Essential hypertension stage II
* Male and female patients
* Age \>= 18 years old

Exclusion Criteria

* Severe hypertension (systolic BP \>= 180 mmHg, diastolic BP \>= 110 mmHg
* Poorly controlled diabetes mellitus or type 1 DM
* History of myocardial infarction, stroke
* Presence of heart failure
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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Responsibility Role SPONSOR

Principal Investigators

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Axthelm, Dr. med.

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigative Site

Pirna, , Germany

Site Status

Countries

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Germany

References

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Axthelm C, Sieder C, Meister F, Pittrow D, Kaiser E. Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index. J Drug Assess. 2012 Dec 25;2(1):1-10. doi: 10.3109/21556660.2012.762367. eCollection 2013.

Reference Type DERIVED
PMID: 27536431 (View on PubMed)

Other Identifiers

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CSPA100ADE01

Identifier Type: -

Identifier Source: org_study_id