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Clinical Trials/NCT00527995
NCT00527995CompletedPhase 3

Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients

Ruhr University of Bochum2 sites in 1 country40 target enrollmentStarted: August 1, 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
35 Years to 70 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •age 35-70
  • •type 2 diabetes mellitus
  • •impotence
  • •with and without hypertension, hypercholesteremia

Exclusion Criteria

  • •patients with history of cardiovascular and malignant disease,
  • •advanced nephropathy (creatinine≥2.2mg/dl)
  • •hepatopathy (liver enzymes higher than the double of normal values)
  • •patients taking nitrates
  • •CHF: NYHA > II
  • •Stable angina: CCS > II

Outcomes

Primary Outcomes

Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.

Time Frame: 60 minutes

Secondary Outcomes

  • Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil.(60 minutes)

Investigators

Sponsor
Ruhr University of Bochum
Sponsor Class
Other

Study Sites (2)

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