CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Laparoscopic Roux-en-Y gastric bypass (LRYGB) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01784848
NCT01784848N/ACompleted
CompareCT.gov

Phase 3 Randomized Controlled Trial Evaluating the Effect of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on Hypertension Medication Reduction, Blood Pressure Levels and Others Cardiovascular Risk Factors.

Hospital do Coracao·interventional·Posted Feb 6, 2013·Updated Apr 7, 2022

In Brief

A clinical study evaluating Laparoscopic Roux-en-Y gastric bypass (LRYGB) and Clinical treatment for Systemic Hypertension and Obesity. Completed, enrolled 100 participants across 3 sites.

Detailed Summary

Phase 3, unicentric, randomized clinical trial, with allocation concealment and intention-to-treat analysis to evaluate the efficacy of videolaparoscopic Roux-en-Y Gastroplasty to decrease the prescription of antihypertensive drugs maintaining normal levels of blood pressure, decrease systemic arterial blood pressure and other risk factors for cardiovascular events compared to clinical treatments of patients with arterial hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Hypertension, Obesity
CountriesBrazil
CollaboratorsEthicon Endo-Surgery

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2013
Enrollment StartMay 1, 2013
Primary CompletionMay 1, 2017
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 13.4 years ago

Interventions

Laparoscopic Roux-en-Y gastric bypass (LRYGB)procedure

Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery

Clinical treatmentother

Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.