The Effects of Doxazosin and Nifedipine on Blood Pressure Variability and Uric Acid in Plasma in Hypertensive Patients

NCT ID: NCT02563405

Last Updated: 2016-07-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-10-31

Brief Summary

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Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.

In addition, recent studies found that the occurrence and development of hypertension, especially essential hypertension, are closely related with hyperuricemia. Serum UA is an independently prognostic indicator for the development of hypertension. Some studies have observed the effects of different kinds of antihypertensive drugs on uric acid level in hypertensive patients. After adjustment, calcium channel blockers are associated with a lower risk of incident gout among people with hypertension. However, the effects of alpha blockers on uric acid in plasma are still not very clear.

Therefore, we performed this study to observe the different effects of alpha blocker and calcium channel blocker on blood pressure variability and uric acid level in hypertensive patients.

Detailed Description

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Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.

In addition, recent studies found that the occurrence and development of hypertension, especially essential hypertension, are closely related with hyperuricemia. Accumulated data has shown that a significant and independent association between the uric acid level and the onset of hypertension in both men and women participants. Serum UA is an independently prognostic indicator for the development of hypertension. Some studies have observed the effects of different kinds of antihypertensive drugs on uric acid level in hypertensive patients. After adjustment, diuretics, β blockers, angiotensin converting enzyme inhibitors and non-losartan angiotensin Ⅱ receptor antagonists are associated with an increased risk of gout. In contrast, calcium channel blockers and losartan are associated with a lower risk of incident gout among people with hypertension. However, the effects of alpha blockers on uric acid in plasma are still not very clear.

Therefore, we performed this study to observe the different effects of alpha blocker and calcium channel blocker on blood pressure variability and uric acid level in hypertensive patients.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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doxazosin

To observe the effects of doxazosin (4 mg) on uric acid in plasma and blood pressure variability after 12 weeks of treatment

Group Type ACTIVE_COMPARATOR

Doxazosin

Intervention Type DRUG

Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.

Nifedipine

Intervention Type DRUG

Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.

nifedipine

To observe the effects of nifedipine (30 mg) on uric acid in plasma and blood pressure variability after 12 weeks of treatment

Group Type ACTIVE_COMPARATOR

Doxazosin

Intervention Type DRUG

Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.

Nifedipine

Intervention Type DRUG

Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.

Interventions

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Doxazosin

Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.

Intervention Type DRUG

Nifedipine

Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Men aged between 18 and 75 included years old Postmenopausal women who are no more than 75 years older. Patients with essential mild to moderate uncomplicated hypertension (DBP\<110mmHg and SBP\<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification, Without antihypertensive treatment in 2 weeks.

Exclusion Criteria

History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.

History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.

History of renal impairment. History of Type I diabetes mellitus or Type II diabetes uncontrolled. History of liver impairment. History of alcoholism or drug abuse. Known symptomatic orthostatic hypotension. Contra-indications to treatment with investigate products.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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uric acid test and 24-hour ambulatory BP monitoring

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yue Li, PHD

Role: CONTACT

86-451-85555673

Jing Shi, MM

Role: CONTACT

86-451-85555672

Facility Contacts

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Yujiao Pan, MM

Role: primary

86-451-85555671

Other Identifiers

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HT-3-UA

Identifier Type: -

Identifier Source: org_study_id

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