|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00571766 |
|
Date of registration:
|
11/12/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy
|
|
Scientific title:
|
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy |
|
Date of first enrolment:
|
November 2007 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00571766 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Fabio Facchinetti, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Modena and Reggio Emilia |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Pregnant women between 18-20 week of gestation with chronic hypertension
Exclusion Criteria:
- Maternal or fetal disease
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypertension in Pregnancy
|
|
Intervention(s)
|
|
Drug: L-Arginine
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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]
|
|
Secondary ID(s)
|
|
Oral L-Arginine
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|