Back to resultsL-arginine Effects on Chronic Hypertension in Pregnancy
Primary Purpose
Hypertension in Pregnancy
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
L-arginine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension in Pregnancy focused on measuring chronic hypertension in pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women between 18-20 weeks of gestation with chronic hypertension
Exclusion Criteria:
- Other maternal or fetal systemic disease
Sites / Locations
- University of Modena and Reggio Emilia
- University of Modena and Reggio Emilia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Oral L-arginine 2 g twice a day, for 14 weeks
oral placebo twice a day for 14 weeks
Outcomes
Primary Outcome Measures
to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00974714
First Posted
September 9, 2009
Last Updated
January 19, 2010
Sponsor
University of Modena and Reggio Emilia
Collaborators
University of Modena
1. Study Identification
Unique Protocol Identification Number
NCT00974714
Brief Title
L-arginine Effects on Chronic Hypertension in Pregnancy
Official Title
Effects of Oral L-arginine on Chronic Hypertension in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Modena and Reggio Emilia
Collaborators
University of Modena
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
Keywords
chronic hypertension in pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral L-arginine 2 g twice a day, for 14 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
oral placebo twice a day for 14 weeks
Intervention Type
Drug
Intervention Name(s)
L-arginine
Intervention Description
Oral L-arginine 2 g twice a day for 14 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
oral placebo 2 g twice a day for 14 weeks
Primary Outcome Measure Information:
Title
to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
14 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women between 18-20 weeks of gestation with chronic hypertension
Exclusion Criteria:
Other maternal or fetal systemic disease
Facility Information:
Facility Name
University of Modena and Reggio Emilia
City
Modena
State/Province
Emilia Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
University of Modena and Reggio Emilia
City
Modena
State/Province
Mo
ZIP/Postal Code
41100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
L-arginine Effects on Chronic Hypertension in Pregnancy
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