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L-arginine Effects on Chronic Hypertension in Pregnancy

This study has been completed.
Sponsor:
Collaborator:
University of Modena
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT00974714
First received: September 9, 2009
Last updated: January 19, 2010
Last verified: September 2009

September 9, 2009
January 19, 2010
September 2007
June 2009   (final data collection date for primary outcome measure)
to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00974714 on ClinicalTrials.gov Archive Site
evaluate if is necessary to add a conventional therapy for hypertension, to evaluate pregnancy outcomes and eventual complications, to evaluate safety of oral L-arginine administration [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
L-arginine Effects on Chronic Hypertension in Pregnancy
Effects of Oral L-arginine on Chronic Hypertension in Pregnancy

The purpose of this study is to evaluate the effects of oral L-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypertension in Pregnancy
  • Drug: L-arginine
    Oral L-arginine 2 g twice a day for 14 weeks
  • Other: placebo
    oral placebo 2 g twice a day for 14 weeks
  • Experimental: 1
    Oral L-arginine 2 g twice a day, for 14 weeks
    Intervention: Drug: L-arginine
  • Placebo Comparator: 2
    oral placebo twice a day for 14 weeks
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women between 18-20 weeks of gestation with chronic hypertension

Exclusion Criteria:

  • Other maternal or fetal systemic disease
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00974714
Facchinetti, Neri Isabella, De Pace Viviana, Monari Francesca, Dante Giulia
Yes
Facchinetti Fabio, University of Modena and Reggio Emilia
University of Modena and Reggio Emilia
University of Modena
Not Provided
University of Modena and Reggio Emilia
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP