Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension

NCT ID: NCT00267176

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

PHASE4

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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This study will investigate the effect on ambulatory blood pressure of lumiracoxib 100 mg once daily versus ibuprofen 600 mg three times a day in osteoarthritis patients with controlled hypertension.

Detailed Description

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Conditions

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Osteoarthritis Controlled 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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lumiracoxib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis of the hand, hip, knee or spine
* High blood pressure (\<140/ 90 mmHg) which is controlled by antihypertensive medication(s).

Exclusion Criteria

• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradkey Sakran, MD

Role: PRINCIPAL_INVESTIGATOR

Southern Illinois Clinical Research

Locations

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Southern Illinois Clinical Research

O'Fallon, Illinois, United States

Site Status

Novartis

Nuremberg, , Germany

Site Status

Countries

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United States Germany

References

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MacDonald TM, Reginster JY, Littlejohn TW, Richard D, Lheritier K, Krammer G, Rebuli R. Effect on blood pressure of lumiracoxib versus ibuprofen in patients with osteoarthritis and controlled hypertension: a randomized trial. J Hypertens. 2008 Aug;26(8):1695-702. doi: 10.1097/HJH.0b013e328302c9fe.

Reference Type RESULT
PMID: 18622250 (View on PubMed)

Other Identifiers

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CCOX189A2428

Identifier Type: -

Identifier Source: org_study_id

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