A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

NCT ID: NCT00386139

Last Updated: 2017-02-07

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

881 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-07-31

Brief Summary

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Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

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

Interventions

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Aliskiren/HCTZ

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients 18 years old or older.
* Patients with a diagnosis of hypertension.
* Patients who are eligible and consent to participate in the study

Exclusion Criteria

* Severe hypertension
* Previous or current diagnosis of heart failure.
* History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
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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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Investigative Centers, , Germany

Site Status

Countries

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United States Germany

References

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Nickenig G, Simanenkov V, Lembo G, Rodriguez P, Salko T, Ritter S, Zhang J. Efficacy of aliskiren/hydrochlorothiazide single-pill combinations in aliskiren non-responders. Blood Press Suppl. 2008 Dec;2:31-40. doi: 10.1080/08038020802507290.

Reference Type RESULT
PMID: 19203020 (View on PubMed)

Other Identifiers

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CSPP100A2332

Identifier Type: -

Identifier Source: org_study_id

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