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CompletedNCT00267176Updated Feb 7, 2017

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

A Phase 4 interventional study of lumiracoxib in Osteoarthritis and Controlled Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,020
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Osteoarthritis
  • Controlled Hypertension

Keywords

  • Osteoarthritis,
  • hypertension,
  • lumiracoxib,
  • ibuprofen,
  • 24-hour blood pressure profile
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 1,020 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All

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

Exclusion criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,020 participants

Interventions

  • Druglumiracoxib
06

What researchers measure

Primary outcomes

  1. Assessment of the 24-hour systolic BP profile of lumiracoxib 100 mg o.d. in comparison to ibuprofen 600 mg t.i.d. after 4 weeks of treatment.

Secondary outcomes

  1. Assessment of the effect of lumiracoxib 100 mg o.d. on diastolic BP derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d.

  2. Assessment of the effect of lumiracoxib 100 mg o.d. on daytime and nighttime BP (systolic and diastolic) derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d.

  3. Assessment of the effect of lumiracoxib 100 mg o.d. on the incidence of significant increases in ABP in comparison to ibuprofen 600 mg t.i.d.

  4. Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the incidence of uncontrolled hypertension in comparison to ibuprofen 600 mg t.i.d.

  5. Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the ABPM profile between 0 and 4 hours after morning dose in comparison to ibuprofen 600 mg t.i.d.

07

Study locations

2 sites
  • Southern Illinois Clinical Research
    O'Fallon, Illinois 62269, United States
  • Novartis
    Nuernberg, Germany
08

References and documents

Publications

  • 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. PubMed 18622250 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00267176
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 20, 2005
Start date
Nov 2005
Primary completion
Sep 2006
Last update
Feb 7, 2017

Study contacts

Bradkey Sakran, MD
principal investigator · Southern Illinois Clinical Research
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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