L-arginine Effects on Chronic Hypertension in Pregnancy

Hypertension in Pregnancy Clinical Trial

Official title:

Effects of Oral L-arginine on Chronic Hypertension in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974714
• Other study ID #: Facchinetti
• Secondary ID: Neri IsabellaDe
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2009
• Last updated: January 19, 2010
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Other maternal or fetal systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Intervention

Drug:
• L-arginine
Oral L-arginine 2 g twice a day for 14 weeks

Other:
• placebo
oral placebo 2 g twice a day for 14 weeks

Locations

Country	Name	City	State
Italy	University of Modena and Reggio Emilia	Modena	Emilia Romagna
Italy	University of Modena and Reggio Emilia	Modena	Mo

Sponsors (2)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia	University of Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation		14 weeks	Yes
Secondary	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		14 weeks	Yes