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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05147753
Other study ID # 7337_20042021
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 11, 2010
Est. completion date June 30, 2014

Study information

Verified date November 2021
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 30, 2014
Est. primary completion date June 30, 2014
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Moxonidine
0.6 mg moxonidine daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Outcome

Type Measure Description Time frame Safety issue
Primary serum Neuropeptide Y levels ELISA 12 weeks
Primary systolic blood pressure mmHg 12 weeks
Primary diastolic blood pressure mmHg 12 weeks
Secondary Weight kg 12 weeks
Secondary Body Mass Index kg/m2 12 weeks
Secondary Total Cholesterol mg/dl 12 weeks
Secondary HDL Cholesterol mg/dl 12 weeks
Secondary LDL Cholesterol mg/dl 12 weeks
Secondary Serum triglycerides mg/dl 12 weeks
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