NCT00571766

Brief Summary

The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women with chronic hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

Enrollment Period

1.1 years

First QC Date

December 11, 2007

Last Update Submit

September 9, 2009

Conditions

Hypertension in Pregnancy

Keywords

chronic hypertension in pregnancychronic Hypertension

Outcome Measures

Primary Outcomes (1)

  • to evaluate blood pressure changes in pregnant women with chronic hypertension during oral arginine or placebo treatment in second trimester of gestation.

    14 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Oral L-Arginine 2 g twice a day for 14 weeks

Drug: L-Arginine

2

PLACEBO COMPARATOR

Placebo 2 g, twice a day for 14 weeks

Drug: Placebo

Interventions

L-ArginineDRUG

Oral L-Arginine 2g, twice a day for 14 weeks

1
PlaceboDRUG

Placebo 2 g twice a day for 14 weeks

2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Maternal or fetal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Modena and Reggio Emilia

Modena, Emilia-Romagna, 41100, Italy

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Arginine

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Fabio Facchinetti, MD

    University of Modena and Reggio Emilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

IT(1)