Combined Antihypertensive Therapy and Sexual Dysfunction
NCT ID: NCT01238705
Last Updated: 2010-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
280 participants
INTERVENTIONAL
2008-04-30
2010-11-30
Brief Summary
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The researchers hypothesize that:
1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension.
2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels.
3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.
Detailed Description
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Treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines.More than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events.
CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic for the treatment of hypertension.The purpose of this study is to compare the impacts of different CCB-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Felodipine,Irbesartan,Sexual Dysfunction
Felodipine add Irbesartan
Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
Irbesartan,150mg/day, Sanofi - Aventis Pharmaceutical company, Registration Number: H20080074.
Felodipine,Metoprolol,Sexual Dysfunction
Felodipine add Metoprolol
Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
Metoprolol Succinate,47.5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: J20050061.
Interventions
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Felodipine add Irbesartan
Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
Irbesartan,150mg/day, Sanofi - Aventis Pharmaceutical company, Registration Number: H20080074.
Felodipine add Metoprolol
Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
Metoprolol Succinate,47.5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: J20050061.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initial hypertension, or without taking any antihypertensive for at least one month.
* Sexual active.
Exclusion Criteria
* Patients with malignant hypertension, coronary heart disease, diabetes, a history of syncope, bradycardia (heart rate \<45 beats / min), atrioventricular block(Ⅱ or Ⅲ degree), sick sinus syndrome, congestive heart failure, a history of cerebral vascular accidents, serious hepatic and kidney dysfunction, a history of serious mental illness, pregnant, taking oral exogenous estrogens (including contraceptives), hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious conflict with sexual partner, severity sexual dysfunction.
* Patients refuse to answer questions, refuse to fill in the questionaires,or do not willing to take blood examination.
18 Years
60 Years
ALL
No
Sponsors
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LanZhou University
OTHER
Responsible Party
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The Second Hospital of LanZhou University
Principal Investigators
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Jing Yu, Professor
Role: STUDY_CHAIR
Lanzhou University Second Hospital
Locations
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The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Countries
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Central Contacts
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Facility Contacts
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Ruixin Ma, Doctor
Role: primary
Jing Yu, Professor
Role: backup
References
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Other Identifiers
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0709TCYA068
Identifier Type: -
Identifier Source: org_study_id