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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Pregnancy Complications
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014