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A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

NCT ID: NCT00171405

Last Updated: 2016-11-18

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-02-28

Brief Summary

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The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.

Detailed Description

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Conditions

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Hypertension

Keywords

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hypertension aliskiren hydrochlorothiazide

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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aliskiren

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
2. absence of ongoing severe adverse events at Visit 10.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigative Site

East Hanover, New Jersey, United States

Site Status

Investigative Site

Deurne, , Belgium

Site Status

Investigative Site

Ste-Fov, , Canada

Site Status

Investigative Site

Krassel, , Germany

Site Status

Investigative Site

Broni, , Italy

Site Status

Investigative Site

Rotterdam, , Netherlands

Site Status

Investigative Site

Lima, , Peru

Site Status

Investigative Site

Moscow, , Russia

Site Status

Investigative Site

Basel, , Switzerland

Site Status

Investigative Site

London, , United Kingdom

Site Status

Countries

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United States Belgium Canada Germany Italy Netherlands Peru Russia Switzerland United Kingdom

References

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Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.

Reference Type RESULT
PMID: 22035463 (View on PubMed)

Other Identifiers

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CSPP100A2302E1

Identifier Type: -

Identifier Source: org_study_id