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Completed

NCT Number: NCT00571766

Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy

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

Completed

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Modena and Reggio Emilia

Modena, Emilia-Romagna, 41100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Maternal or fetal disease

Treatment and study plan

L-arginine

Drug

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

Placebo

Drug

Placebo 2 g twice a day for 14 weeks

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.

    Time frame: 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.

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 12, 2007
Registry last updated
Sep 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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