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TerminatedNCT00785811Updated Mar 16, 2011

Effect of Chronic Supplementation of L-arginine in the Muscular Performance

A Phase 4 interventional study of L-arginine aspartate (Targifor) and Placebo L-arginine aspartate (Targifor) in Muscular Fatigue, sponsored by Sanofi. Terminated at 1 site in Brazil. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-16.

Sponsored by Sanofi · Phase 4, Interventional, and Supportive care

Why this study was terminated
Required by the investigator. The site could not recruit patients anymore.
Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular force the quadriceps.

02

Conditions studied

  • Muscular Fatigue

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03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 36 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Healthy young adults for both sex; Age between 20 and 55 years; Slight or moderate physical activity, 30 minutes per day, at least 3 times a week;

Exclusion criteria

Exclusion criteria:

Cardiac or pulmonary disease; Previous history of knee surgery or skeletal muscular dysfunctions in hip, knee or ankle joints; Athletic person (intensive anaerobic activity); None practiced of physical activity regularly; Medications usage

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    1

    L-arginine aspartate (Targifor)

    Drug: L-arginine aspartate (Targifor)

  • Placebo comparator
    2

    Placebo

    Drug: Placebo L-arginine aspartate (Targifor)

Interventions

  • DrugL-arginine aspartate (Targifor)

    3g of L-arginine taken orally in a single daily dose for 8 weeks

  • DrugPlacebo L-arginine aspartate (Targifor)

    Placebo of L-arginine taken orally in a single daily dose for 8 weeks

06

What researchers measure

Primary outcomes

  1. Fatigue Resistance Factor (FRF)

    Time frame: Throughout the study

Secondary outcomes

  1. Maximum force in Newton (N) and fast or explosive force

    Time frame: at time 30% of the maximum isometric force

  2. Maximum force in Newton (N) and fast or explosive force

    Time frame: at time 50% of the maximum isometric force

  3. Maximum force in Newton (N) and fast or explosive force

    Time frame: at time 90% of the maximum isometric force

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Sao Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00785811
Lead sponsor
Sanofi
First posted
Nov 5, 2008
Start date
Oct 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Mar 16, 2011

Study contacts

Jaderson Lima
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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