NCT02031861

Brief Summary

The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate essential hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

April 1, 2014

Enrollment Period

5 months

First QC Date

January 8, 2014

Last Update Submit

February 3, 2015

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (2)

  • change in morning blood pressure surge from baseline

    12 weeks

  • change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline

    12 weeks

Secondary Outcomes (14)

  • change in morning blood pressure from baseline

    12 weeks

  • T/P ratio

    12 weeks

  • average reduction in systolic blood pressure from 18 to 24 hours after administration

    12 weeks

  • average reduction in diastolic blood pressure from 18 to 24 hours after administration

    12 weeks

  • smoothness index

    12 weeks

  • +9 more secondary outcomes

Other Outcomes (1)

  • clinical laboratory test and adverse event

    12 weeks

Study Arms (2)

nifedipine CR tablets (Xin Ran)

EXPERIMENTAL

Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period.

Drug: nifedipine CR tablets (Xin Ran)

nifedipine CR tablets (Adalat)

ACTIVE COMPARATOR

Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period.

Drug: nifedipine CR tablets (Adalat)

Interventions

nifedipine CR tablets (Xin Ran)DRUG
nifedipine CR tablets (Xin Ran)
nifedipine CR tablets (Adalat)DRUG
nifedipine CR tablets (Adalat)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily participate and must sign informed consent form
  • Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
  • Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg

You may not qualify if:

  • Secondary hypertension and malignant hypertension
  • Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
  • Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
  • Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
  • Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
  • Kock pouch
  • Sever gastrointestinal stenosis
  • Abnormal laboratory values with clinical significance, including serum potassium \<3.5 or \>5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) \>2-fold upper limit of normal (ULN), Cr \>ULN
  • Uric acid \>ULN with the diagnosis of gout
  • Gastrointestinal abnormalities or surgery that may interfere with drug absorption
  • Hyperthyroidism or hypothyroidism
  • Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
  • Heavy smokers (\>25 cigarettes every day), alcoholics (\>250 ml liquor every day), drug addicts
  • Psychological diseases, acrasia, cannot express explicitly
  • Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pingjin Gao

    Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 5, 2015

Record last verified: 2014-04

Locations

CN(1)