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Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy

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.
ClinicalTrials.gov Identifier: NCT00571766
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Hypertension in Pregnancy Drug: L-Arginine Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : November 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Maternal or fetal 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): 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

Responsible Party: Fabio Facchinetti, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT00571766     History of Changes
Other Study ID Numbers: Oral L-Arginine
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

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