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OpenTrials
Completed

NCT Number: NCT00267176

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Cardiovascular Diseases Controlled Hypertension Hypertension Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis, Nuremberg, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Lumiracoxib

Drug

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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 4-week, Multicentre, Randomized, Double-blind, Double-dummy, Parallel Group Ambulatory Blood Pressure Monitoring Study to Investigate Whether Treatment With Lumiracoxib 100 mg Once Daily Results in an Improved 24-hour Blood Pressure Profile Compared to Ibuprofen 600 mg Three Times a Day in Osteoarthritis Patients With Controlled Hypertension

Important dates

Study start
2005
Primary completion
2006
First posted
Dec 20, 2005
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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