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PROVIDENCE-1: Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients
This study is ongoing, but not recruiting participants.
First Received: November 9, 2005   Last Updated: August 20, 2008   History of Changes
Sponsored by: ActivBiotics
Information provided by: ActivBiotics
ClinicalTrials.gov Identifier: NCT00251849
  Purpose

The objective of this study is to determine whether rifalazil can significantly increase peak walking time (PWT) in patients with peripheral arterial disease (PAD).


Condition Intervention Phase
Peripheral Vascular Diseases
Intermittent Claudication
Drug: Rifalazil
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients

Resource links provided by NLM:


Further study details as provided by ActivBiotics:

Primary Outcome Measures:
  • The efficacy endpoint is change from baseline in PWT
  • The safety endpoints are adverse event rates, rates of clinically significant laboratory abnormalities, vital signs, and physical exam abnormalities, rate of vascular death, myocardial infarction (MI), stroke, revascularization or vascular procedures

Estimated Enrollment: 274
Study Start Date: November 2005
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients between 40 and 80 years of age, inclusive.
  • The patient has seropositive evidence of Chlamydia pneumoniae defined by immunoglobulin G antibody titers.
  • The patient has a diagnosis of intermittent claudication due to PAD at screening.
  • The patient's maximal effort PWT is limited only by severe claudication symptoms.
  • If the patient is taking cilostazol or pentoxifylline and has been on a stable dose of the medication for at least 6 months prior to screening. Patients who have recently discontinued medications for PAD and/or intermittent claudication must "wash-out" for at least one month prior to screening.
  • The patient has been on a stable dose of statin therapy for at least 6 months prior to screening.Patients who have recently discontinued statin therapy must "wash-out" for at least one month prior to screening.
  • Male and female patients must agree to use an effective form of birth control throughout the study period.

Exclusion Criteria:

  • The patient has critical limb ischemia as evidenced by ischemic rest pain, ulceration, or gangrene.
  • The patient has had a major amputation of the leg or any other amputation that limits walking ability.
  • The patient is planned for surgical/endovascular intervention for PAD during the course of the study.
  • The patient has or is being treated or evaluated for tuberculosis.
  • The patient has a known immunodeficient state (e.g., positive for human immunodeficiency virus) or is being treated with immunosuppressive drugs including high dose steroids or cyclosporine.
  • The patient has an active infection requiring systemic or oral antibiotics.
  • The patient has an uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis. Patients who develop autoimmune disease during the course of the study must be withdrawn.
  • The patient's PWT is limited by symptoms other than claudication (shortness of breath, fatigue, angina, or arthritis).
  • The patient has a history of alcohol abuse, illicit drug use or drug abuse or significant mental illness.
  • The patient has a known or suspected allergy to the study medication(s) or class of study medication (rifamycins) to be administered.
  • The patient chronically uses antibacterials or has previously received rifalazil or any rifamycin (e.g.

rifampin).

  • The patient has uncontrolled hypertension (resting blood pressure > 160/100 mm Hg), uncontrolled moderate to severe congestive heart failure (CHF), or uncontrolled arrhythmic disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251849

  Show 48 Study Locations
Sponsors and Collaborators
ActivBiotics
  More Information

No publications provided by ActivBiotics

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: ABI-1648-022
Study First Received: November 9, 2005
Last Updated: August 20, 2008
ClinicalTrials.gov Identifier: NCT00251849     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by ActivBiotics:
Intermittent Claudication

Study placed in the following topic categories:
Arterial Occlusive Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Signs and Symptoms
Peripheral Vascular Diseases
Chlamydia Infections
Vascular Diseases
Intermittent Claudication
Antitubercular Agents
Arteriosclerosis
KRM 1648
Pneumonia

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Anti-Infective Agents
Peripheral Vascular Diseases
Vascular Diseases
Arteriosclerosis
KRM 1648
Pharmacologic Actions
Antibiotics, Antitubercular
Signs and Symptoms
Anti-Bacterial Agents
Therapeutic Uses
Intermittent Claudication
Cardiovascular Diseases
Antitubercular Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on September 10, 2009