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

NCT02563405 | Unknown Phase 2 DMC

• 1 other identifier: HT-3-UA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

alpha receptor blocker; uric acid; CCB; blood pressure variability

Outcome Measures

Primary Outcomes (1)

• 24-hour Ambulatory Blood Pressure Monitoring

  3 years

Secondary Outcomes (1)

• plasma uric acid level

  3 years

Study Arms (2)

doxazosin

ACTIVE COMPARATOR

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

Drug: Doxazosin; Drug: Nifedipine

nifedipine

ACTIVE COMPARATOR

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

Drug: Doxazosin; Drug: Nifedipine

Interventions

Doxazosin DRUG

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

doxazosin; nifedipine

Nifedipine DRUG

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

doxazosin; nifedipine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

uric acid test and 24-hour ambulatory BP monitoring

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Doxazosin; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Yue Li, PHD

CONTACT

86-451-85555673; ly99ly@vip.163.com

Jing Shi, MM

CONTACT

86-451-85555672; yidashijing@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 30, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: July 28, 2016

Record last verified: 2015-09

Locations

CN (1)