NCT05147753

Brief Summary

Treatment with monotherapy of moxonidine 0.6 mg daily in treatment-naïve subjects with mild or moderate hypertension

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4 obesity

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
Last Updated

December 7, 2021

Status Verified

November 1, 2021

Enrollment Period

4.5 years

First QC Date

November 18, 2021

Last Update Submit

November 24, 2021

Conditions

ObesityHypertension

Keywords

hypertensionobesityNeuropeptide Ymoxonidine

Outcome Measures

Primary Outcomes (3)

  • serum Neuropeptide Y levels

    ELISA

    12 weeks

  • systolic blood pressure

    mmHg

    12 weeks

  • diastolic blood pressure

    mmHg

    12 weeks

Secondary Outcomes (6)

  • Weight

    12 weeks

  • Body Mass Index

    12 weeks

  • Total Cholesterol

    12 weeks

  • HDL Cholesterol

    12 weeks

  • LDL Cholesterol

    12 weeks

  • +1 more secondary outcomes

Study Arms (1)

Group

EXPERIMENTAL

0.6 mg moxonidine daily

Drug: Moxonidine

Interventions

MoxonidineDRUG

0.6 mg moxonidine daily

Group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • treatment-naïve subjects with mild or moderate hypertension according to Joint National Committee 7 and European Society Hypertension / European Society Cardiology 2008 (Stage 1: Systolic Blood Pressure =140-159 mmHg, Diastolic Blood Pressure =90-99 mmHg, and Stage 2: Systolic=160-179 mmHg, Diastolic=100-109 mmHg) that require monotherapy

You may not qualify if:

  • age beyond 25-75 years,
  • not taking currently anti-hypertensive medication
  • not taking anti-diabetic or lipid lowering medication and other diseases or conditions that may influence blood pressure, heart rate and catecholamines' and Neuropeptide Y levels, including anemia, fever, stage III hypertension, coronary artery disease, recent (less than 6 months) myocardial infraction or stroke, heart failure, secondary hypertension, diabetes mellitus, abnormal thyroid status or other obesity-related endocrinopathies, pregnancy, kidney failure, alcohol abuse, malignancies, depression or other psychiatric illnesses, such as schizophrenia,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityHypertension

Interventions

moxonidine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Eleni Karlafti, MD, PhD

    AHEPA University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine-Diabetology

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 7, 2021

Study Start

January 11, 2010

Primary Completion

June 30, 2014

Study Completion

June 30, 2014

Last Updated

December 7, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share