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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral L-arginine on Chronic Hypertension in Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT00974714     History of Changes
Other Study ID Numbers: Facchinetti, Neri Isabella, De Pace Viviana, Monari Francesca, Dante Giulia
Study First Received: September 9, 2009
Last Updated: January 19, 2010
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013