Moxonidine Effects on Neuropeptide Y

November 24, 2021 updated by: Prof. Triantafyllos Didangelos, Aristotle University Of Thessaloniki

Effects of Moxonidine Administration on Serum Neuropeptide Y Levels in Hypertensive Individuals: A Prospective Observational Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment with 0.6 mg moxonidine daily in treatment-naïve subjects with mild or moderate hypertension according to guidelines (Stage 1: Systolic Blood Pressure =140-159 mmHg, Diastolic Blood Pressure =90-99 mmHg, and Stage 2: systolic blood pressure=160-179 mmHg, diastolic blood pressure=100-109 mmHg) that require monotherapy and reevaluation after 12 weeks

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group
0.6 mg moxonidine daily
Drug: Moxonidine
0.6 mg moxonidine daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum Neuropeptide Y levels
Time Frame: 12 weeks
ELISA
12 weeks
systolic blood pressure
Time Frame: 12 weeks
mmHg
12 weeks
diastolic blood pressure
Time Frame: 12 weeks
mmHg
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 12 weeks
kg
12 weeks
Body Mass Index
Time Frame: 12 weeks
kg/m2
12 weeks
Total Cholesterol
Time Frame: 12 weeks
mg/dl
12 weeks
HDL Cholesterol
Time Frame: 12 weeks
mg/dl
12 weeks
LDL Cholesterol
Time Frame: 12 weeks
mg/dl
12 weeks
Serum triglycerides
Time Frame: 12 weeks
mg/dl
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Eleni Karlafti, MD, PhD, Ahepa University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2010

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

June 30, 2014

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7337_20042021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Moxonidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe