NCT01956786

Brief Summary

To evaluate the efficacy of Amlodipine-Folic Acid Tablets on reduction of blood pressure and plasma total homocysteine.

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
540

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

September 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 8, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

September 30, 2013

Last Update Submit

September 30, 2013

Conditions

Essential Hypertension

Keywords

AmlodipineFolic AcidHomocysteineBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Combined effective rate of blood pressure and plasma homocysteine reduction

    Blood pressure was examined at baseline and every 2 weeks for a total period of 8 weeks.Blood homocysteine concentrations were measured at baseline and at 4th and 8th week of the trial.

Secondary Outcomes (1)

  • Blood pressure reduction or plasma homocysteine reduction

    Blood pressure was examined at baseline and every 2 weeks of a total period of 8 weeks. Blood homocysteine concentrations was examined at baseline and at 4th and 8th week of the trial.

Study Arms (3)

Amlodipine

ACTIVE COMPARATOR

5mg amlodipine,once daily for 8 weeks

Drug: Amlodipine

Amlodipine-FA tablet,low dose group

EXPERIMENTAL

5mg amlodipine combined with 0.4mg of folic acid (FA),once daily for 8 weeks.

Drug: Amlodipine-FA tablet,low dose group

Amlodipine-FA tablet,high dose group

EXPERIMENTAL

5mg amlodipine combined with 0.8mg of folic acid (FA),once daily for 8 weeks.

Drug: Amlodipine-FA tablet,high dose group

Interventions

Amlodipine-FA tablet,low dose groupDRUG

5mg amlodipine combined with 0.4mg folic acid,once daily (Low-dose group)

Also known as: low dose
Amlodipine-FA tablet,low dose group
Amlodipine-FA tablet,high dose groupDRUG

5mg amlodipine combined with 0.8mg folic acid,once daily (High-dose group)

Also known as: high dose
Amlodipine-FA tablet,high dose group
AmlodipineDRUG

5mg amlodipine,once daily

Also known as: control
Amlodipine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75 years;
  • Sedentary systolic blood pressure between 140 mmHg and 180 mmHg, and/or sedentary diastolic blood pressure between 90 mmHg and 110 mmHg;
  • Plasma homocysteine ≥ 10μmol/L;
  • ACEI-intolerance
  • Signed the written informed consent.

You may not qualify if:

  • Pregnant women or women within lactation period;
  • Hypersensitive to Calcium Channel Blocker (CCB) or folic acid;
  • Easily hypersensitiveness;
  • Diagnosed secondary hypertension or skeptical secondary hypertension;
  • Severe hypertension (sedentary systolic blood pressure greater than or equal to 180 mmHg and/or sedentary diastolic blood pressure greater than or equal to 110 mmHg)
  • Severe diseases:
  • Cardiovascular system:Diagnosed cardia insufficiency (New York Health Association \[NYHA\] Ⅲ level and higher);Hypertrophic obstructive cardiomyopathy (HOCM);Clinical significantly Valvular Disease of the Heart (VDH);Acute coronary syndrome or coronary artery interventional therapy or coronary artery bypass graft within three months;Severe arrhythmia such as atrial flutter, atrial fibrillation, atrioventricular block above Ⅱlevel, et al;
  • Alimentary system:Active virus hepatitis;Any of alanine aminotransferase (ALT), aspartate aminotransferase (AST), galactosylhydroxylysyl glucosyltransferase (GGT), alkaline phosphatase (ALP), total bilirubin (TBIL), Direct Bilirubin (DB) was above 2 times of it's normal value upper limit, albumin (ALB) greater than 30 g/L;Stomach bulk resect and gastrojejunostomy;Stomach intestine malabsorption;
  • Urinary system:Serum creatinine greater than or equal to 200 mmol/L;Diagnosed stenosis of renal artery, solitary kidney;Renal transplantation;
  • Endocrine system:Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting glucose greater than or equal to 11.1 mmol/L);Diagnosed and uncontrolled hyperthyrosis;
  • Respiratory system:Pulmonary Heart Disease;Chronic Obstructive Pulmonary Disease(COPD);
  • Neuropsychiatric system:Transient Ischemia Attach (TIA) or stroke within 3 months;Severe peripheral nerve or vegetative nerve functional disturbance; Psyche or nervous system dysfunction;Drugs or alcohol dependence;
  • Others:Malignant tumor, malnutrition, haematogenesis dysfunction, et al;
  • Obviously abnormal laboratory examination or signs;
  • Taking other antihypertensive drugs and unwilling to stop;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, 221006, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong Univesity

Shanghai, Shanghai Municipality, 310000, China

RECRUITING

Related Publications (1)

  • Bao H, Huang X, Li P, Sheng C, Zhang J, Wang Z, Song D, Hu L, Ding C, Cheng Z, Yao C, Chen G, Cui Y, Qin X, Tang G, Wang X, Huo Y, Cheng X, Wang J. Combined use of amlodipine and folic acid are significantly more efficacious than amlodipine alone in lowering plasma homocysteine and blood pressure among hypertensive patients with hyperhomocysteinemia and intolerance to ACEI: A multicenter, randomized, double-blind, parallel-controlled clinical trial. J Clin Hypertens (Greenwich). 2023 Aug;25(8):689-699. doi: 10.1111/jch.14697. Epub 2023 Jul 11.

    PMID: 37433173DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Contraceptives, OralAmlodipine

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wang Jiguang, MD

    Ruijin Hospital, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

October 8, 2013

Record last verified: 2013-07

Locations

CN(3)