NCT00655993

Brief Summary

Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

11 months

First QC Date

April 4, 2008

Last Update Submit

April 24, 2023

Conditions

COPDInflammation

Keywords

COPDInflammationCRP levelssimvastatin

Outcome Measures

Primary Outcomes (1)

  • serum CRP levels

    9 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

placebo drug

Drug: simvastatin

2

ACTIVE COMPARATOR

simvastatin

Drug: simvastatin

Interventions

simvastatinDRUG

40 mg po daily

12

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medically optimized COPD patients
  • Age 40-79 years.
  • serum CRP levels \>3mg/l

You may not qualify if:

  • Current smoker
  • COPD exacerbation in the last 2 months.
  • Active hepatic or severe renal dysfunction.
  • connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (\>10,000 white blood cells) or thrombocytosis (\>450,000 platelets).
  • Recent h/o myocardial infarction, angina in the last 6 months.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Loma Linda Health Care System

Loma Linda, California, 92357, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveInflammation

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Lennard Specht, M.D.

    VA Loma Linda Health Care System

    PRINCIPAL INVESTIGATOR

  • Hemal J. Parekh, M.D.

    VA Loma LInda Healthcare System

    PRINCIPAL INVESTIGATOR

  • James D. Anholm, M.D.

    VA Loma Linda Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

August 1, 2014

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)