A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure (HCT3012-X-111)

June 16, 2011 updated by: NicOx

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Tempe, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Buena Park, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Boynton Beach, Florida, United States
    • Georgia
      • Stockbridge, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Newburgh, Indiana, United States
      • Terre Haute, Indiana, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Montana
      • Billings, Montana, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Edison, New Jersey, United States
    • New York
      • Binghamton, New York, United States
      • Johnson City, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Clarksville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: naproxcinod 375 mg - 750 mg -1125 mg bid
dose escalating
Drug: naproxcinod 375 mg -750 mg -1125 mg bid
naproxcinod 375 mg -750 mg -1125 mg bid
Active Comparator: naproxen 250 mg -500 mg -750 mg bid
dose escalating
Drug: naproxen 250 mg - 500mg -750 mg bid
naproxen 250 mg - 500mg -750 mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
11 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NicOx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCT3012-X-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on naproxcinod 375 mg -750 mg -1125 mg bid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe