CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 202 enrolled
Drug / intervention
Bisoprololdrug
Likely dose
Bisoprolol 5 milligramfrom 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/NCT01066039
NCT01066039Phase 4Completed
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A Prospective, Multi-center, Open-label, Single Arm Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II DIAbetic patieNTs With Suboptimal Blood Pressure Control (GIANT Study)

Merck KGaA, Darmstadt, Germany·interventional·Posted Feb 10, 2010·Updated Jul 4, 2014

In Brief

A Phase 4 clinical trial evaluating Bisoprolol for Hypertension and Diabetes Mellitus, Type II. Completed, enrolled 202 participants across 1 site.

Detailed Summary

This is a 24-week, prospective, multicenter, open-label, single-arm study to assess the effect of bisoprolol on glycemic level in Type 2 diabetes mellitus (T2DM) controlled subjects with hypertension. The hypothesis of study is that there is no change in glycemic level and lipid metabolism as determined by glycosylated hemoglobin (HbA1c) using bisoprolol in T2DM subjects with suboptimal blood pressure (BP) control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Diabetes Mellitus, Type II
CountriesSouth Korea
CollaboratorsMerck Ltd.

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2010
Enrollment StartApr 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.4 years ago

Interventions

Bisoprololdrug

Bisoprolol tablet will be administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure is not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose will be adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose will be reduced to 2.5 mg.