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NCT00571766 Clinical Trial

Effects of Oral L-Arginine 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 NCT00571766
Other study ID # Oral L-Arginine
Secondary ID
Status Completed
Phase Phase 3
First received December 11, 2007
Last updated September 9, 2009
Start date November 2007
Est. completion date December 2008

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 in pregnant women with chronic hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Maternal or fetal 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

Intervention

Drug:
• L-Arginine
Oral L-Arginine 2g, twice a day for 14 weeks
• Placebo
Placebo 2 g twice a day for 14 weeks

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

Sponsors (1)
Lead Sponsor Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary to evaluate blood pressure changes in pregnant women with chronic hypertension during oral arginine or placebo treatment in second trimester of gestation. 14 weeks Yes
Secondary 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. 14 weeks Yes
See also
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