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Completed

NCT Number: NCT00662610

A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure

To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mobile, Alabama, United States

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About this study

This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 1:1 ratio.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men/Women, 40 or older, diagnosed with hip or knee Osteoarthritis.
  • Hypertensive patient with treated and controlled essential hypertension.
  • Must receive at least one antihypertensive treatment from the following drug classes: Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB) or Beta-Blocker (BB).
  • Must be current chronic user of NSAIDS or acetaminophen.
  • Must discontinue all analgesic therapy at Screening.

Exclusion criteria

  • More than two different classes of antihypertensive drugs.
  • Uncontrolled diabetes.
  • Hepatic or renal impairment.
  • A history of alcohol/drug abuse.
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
  • History of congestive heart failure.
  • Clinically relevant abnormal ECG.
  • Current or expected use of anticoagulants.
  • Current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
  • Participation within 30 days prior to pre-screening in another investigational study.

Treatment and study plan

naproxcinod 375 mg -750 mg -1125 mg bid

Drug

naproxcinod 375 mg -750 mg -1125 mg bid

naproxen 250 mg - 500mg -750 mg bid

Drug

naproxen 250 mg - 500mg -750 mg bid

Primary outcomes

  1. To characterize the 24-hour arterial blood pressure profile of different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration.

    Time frame: 11 weeks

Secondary outcomes

  1. To evaluate the general safety and tolerability as well as the PK/PD profile of different doses of naproxcinod compared to different doses of naproxen.

    Time frame: 11 weeks

Sponsors and collaborators

Lead sponsor

NicOx

Industry

Registry information

Official study title

A 12-Week, Phase 1, Multicenter, Double-Blind, Randomized, Dose Ranging, Forced Titration, Naproxen-Controlled, Parallel-Group, Pharmacodynamic Study, to Assess the Effects Different Doses of Naproxcinod and Naproxen on Arterial Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Osteoarthritis Patients With Controlled Essential Hypertension

Acronym: HCT3012-X-111

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 21, 2008
Registry last updated
Jun 17, 2011

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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