NCT02513927

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Aug 2015

Typical duration for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

2.2 years

First QC Date

July 21, 2015

Last Update Submit

September 28, 2015

Conditions

Hypertension

Keywords

Blood pressure variabilityCCBbeta-receptor blockersheart rate

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)

A

ACTIVE COMPARATOR

To observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.Then to observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment.

Drug: metoprololDrug: Nifedipine

B

ACTIVE COMPARATOR

To observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. Then to observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.

Drug: metoprololDrug: Nifedipine

Interventions

metoprololDRUG

Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.

AB
NifedipineDRUG

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

AB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Twenty-four-hour ambulatory BP monitoring

Budapest, Budapest, Hungary

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

MetoprololNifedipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Yue Li, PHD

CONTACT

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

Jing Shi, MM

CONTACT

86-451-85555672yidashijing@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

July 21, 2015

First Posted

August 3, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

HU(1)