Back to resultsEffects of Oral L-Arginine 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, chronic Hypertension
Eligibility Criteria
Inclusion Criteria:
- Pregnant women between 18-20 week of gestation with chronic hypertension
Exclusion Criteria:
- Maternal or fetal disease
Sites / Locations
- 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
Placebo 2 g, twice a day for 14 weeks
Outcomes
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.
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.
Full Information
NCT ID
NCT00571766
First Posted
December 11, 2007
Last Updated
September 9, 2009
Sponsor
University of Modena and Reggio Emilia
1. Study Identification
Unique Protocol Identification Number
NCT00571766
Brief Title
Effects of Oral L-Arginine 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
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Modena and Reggio Emilia
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 in pregnant women with chronic hypertension.
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, chronic Hypertension
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
Placebo 2 g, twice a day for 14 weeks
Intervention Type
Drug
Intervention Name(s)
L-Arginine
Intervention Description
Oral L-Arginine 2g, twice a day for 14 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 2 g twice a day for 14 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women between 18-20 week of gestation with chronic hypertension
Exclusion Criteria:
Maternal or fetal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Facchinetti, MD
Organizational Affiliation
University of Modena and Reggio Emilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Modena and Reggio Emilia
City
Modena
State/Province
Emilia Romagna
ZIP/Postal Code
41100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy
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