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L-arginine Effects on Chronic Hypertension in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974714
First Posted: September 10, 2009
Last Update Posted: January 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Modena
Information provided by:
University of Modena and Reggio Emilia
  Purpose
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.

Condition Intervention Phase
Hypertension in Pregnancy Drug: L-arginine Other: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral L-arginine on Chronic Hypertension in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral L-arginine 2 g twice a day, for 14 weeks
Drug: L-arginine
Oral L-arginine 2 g twice a day for 14 weeks
Placebo Comparator: 2
oral placebo twice a day for 14 weeks
Other: placebo
oral placebo 2 g twice a day for 14 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other maternal or fetal systemic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974714


Locations
Italy
University of Modena and Reggio Emilia
Modena, Emilia Romagna, Italy, 41100
University of Modena and Reggio Emilia
Modena, Mo, Italy, 41100
Sponsors and Collaborators
University of Modena and Reggio Emilia
University of Modena
  More Information

Responsible Party: Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT00974714     History of Changes
Other Study ID Numbers: Facchinetti
Neri Isabella ( Other Grant/Funding Number: Fabio Facchinetti )
De Pace Viviana ( Other Grant/Funding Number: Fabio Facchinetti )
Monari Francesca ( Other Grant/Funding Number: Fabio Facchinetti )
Dante Giulia ( Other Grant/Funding Number: Fabio Facchinetti )
First Submitted: September 9, 2009
First Posted: September 10, 2009
Last Update Posted: January 20, 2010
Last Verified: September 2009

Keywords provided by University of Modena and Reggio Emilia:
chronic hypertension in pregnancy

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications