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Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy

This study has been completed.
Sponsor:
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT00571766
First received: December 11, 2007
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women with chronic hypertension.


Condition Intervention Phase
Hypertension in Pregnancy
 Drug: L-Arginine
Drug: 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 in pregnant women with chronic hypertension during oral arginine or placebo treatment in second trimester of gestation. [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate if is necessary add a conventional therapy for hypertension, to evaluate the maternal and fetal outcomes and possible complications, to evaluate the safety of L-Arginine. [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (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 2g, twice a day for 14 weeks
Placebo Comparator: 2
Placebo 2 g, twice a day for 14 weeks
 Drug: Placebo
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:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Maternal or fetal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571766

Locations
Italy
University of Modena and Reggio Emilia
Modena, Emilia Romagna, Italy, 41100
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
Principal Investigator: Fabio Facchinetti, MD University of Modena and Reggio Emilia
  More Information

No publications provided

Responsible Party: Fabio Facchinetti, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT00571766     History of Changes
Other Study ID Numbers: Oral L-Arginine
Study First Received: December 11, 2007
Last Updated: September 9, 2009
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013