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Trial registered on ANZCTR


Registration number
ACTRN12611000778987
Ethics application status
Approved
Date submitted
20/07/2011
Date registered
26/07/2011
Date last updated
26/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Captopril and Nifedipine in Treatment of Hypertension in Children with Post-streptoccal Acute Glomerulonephritis with Hypertension- A Randomized Control Trial
Scientific title
Evaluation of Captopril and Nifedipine in Treatment of Hypertension in Children with Post-streptoccal Acute Glomerulonephritis with Hypertension- A Randomized Control Trial
Secondary ID [1] 262573 0
NIL
Universal Trial Number (UTN)
U1111-1122-6303
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Control of Blood Pressure in Patients with Post-sterptococcal Acute Glomerulonephritis (PSAGN) 268232 0
Renal profiles in patients with Post-streptococcal Acute Glomerulonephritis (PSAGN) 268233 0
Condition category
Condition code
Cardiovascular 268365 268365 0 0
Hypertension
Renal and Urogenital 268366 268366 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Randomized Control Trial study with 2 independent groups.
We will be using a generic Captopril (CAPTOHEXAL (Registered Trademark) 12.5 COR) produced by Hexal AG, Germany for Captopril and a generic Nifedipine produced by Sai Mirra Innopharm from India.
The Nifedipine, a 3,5-dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate compound, is rapidly absorbed after oral administration. It is detectable in the serum after 10 – 15 minutes and the peak blood levels occur in approximately 30 minutes. Its half life is approximately 2 hours. It is metabolized mainly in the liver.
The Captopril (CAPTOHEXAL (registered Trademark) 12.5 COR), is a (2S)-1-[(2S)-2-methyl-3-sulfanylpropanoyl] pyrrolidine-2-carboxylic acid compound. Following oral administration of Captopril, rapid absorption occurs and detectable in 15 minutes with peak blood levels at about one hour. After administration oral dose, the apparent elimination half-life for total radioactivity in blood is about 12 hours for the 12 to 48 hours time interval. It is primarily eliminated in the urine.
The Nifedipine will be packed in a dosing of 5 mg each and the Captopril will be packed in 6.25mg each. Both medications will be wrapped in an aluminum foil. The packing of these medications into aluminum foil will be done by the pharmacist and should be identical so to eliminate bias. With this method, the caretaker, the patient and researcher will be blinded with the treatment. Block randomization will be done by a computer program. A list containing computer-generated assigned number then will be generated. The list will be kept by the pharmacist. The researcher or the first doctor in charge of patient will enroll the patient once consent is taken and inclusion criteria are fulfilled and the pharmacist will enroll the patient according to the randomization list.
Before the patient is started on the treatment, parameters such as duration of illness before presentation, history of preceding infection, weight and height, blood pressure before treatment, renal profile, full blood count, complement levels, ASOT and anti- DNase B level will be recorded.
The Nifedipine and Captopril will be titrated according to response. The dosage of Nifedipine and Captopril given will be based on weight and the age of the patient. This will ensure that the given drug will fall onto the therapeutic ranges of each medication.
After the medication is initiated, the blood pressure will be monitored 1/2 hour, 1 hour, 4 hours, 8 hours, 12 hours and 24 hours after administration on day one and subsequently daily (early morning at 8.00 am) during the course of the treatment, until the patient is discharged. Blood pressure will be taken in supine position and using a single automated BP monitoring device (DINAMAP (Registerd Trademark) with appropriate cuff size using according to the NHBPEP (National High Blood Pressure Education Program) Working Group on High Blood Pressure in Children and Adolescence 2004 recommendations.
Additional antihypertensive can be used to control the blood pressure if it is not controlled after 3 hours of starting the treatment and if there is a risk of patient developing hypertensive encephalopathies. Only Frusemide can be used for this and can be given as per needed basis. If the risk of hypertensive encephalopathy in inevitable, patient will be started on intravenous antihypertensive, i.e Sodium Nitroprusside and patient will be excluded from the study. Apart from blood pressure, we will monitor the Blood Urea, Creatinine, [UK/(UNa+K)] Ratio, and Beta-2 Microglobulin, on the third day of the treatment to compare the levels between pretreatment and the post treatment difference.
Statistical analysis will be done by using SPSS software version 12.0.1, with results of the blood pressure, total duration of medication, hospitalization and normalization of BP will be explained in means and compared. It is then tested with Independent Student T- test for confirmation of the difference of blood pressure means. As for the duration of blood pressure normalization and duration of hospital stay, Mann- Whitney test will be used for confirmation.
Intervention code [1] 266903 0
Treatment: Drugs
Comparator / control treatment
The study compares between two drugs in controlling BP in Post-streptococcal Acute Glomerulonephritis (PSAGN). One group will receive Captopril and the other Nifedipine (randomised).
Control group
Active

Outcomes
Primary outcome [1] 269137 0
To compare the of blood pressure control in patients with PSAGN with hypertension in patients receiving Captopril and Nifedipine. This will be determine by normalization of blood pressure control by means of automated blood pressure measuring device.
Timepoint [1] 269137 0
During hospital admission until discharge
Primary outcome [2] 269279 0
To compare the blood pressure control in patients with PSAGN with hypertension in patients receiving Captopril and Nifedipine by means of reading of blood pressure using ann automated blood pressure machine.
Timepoint [2] 269279 0
During hospital admission until discharge
Secondary outcome [1] 276998 0
To determine the duration needed for blood pressure control (i.e Systolic and diastolic BP of < 95 percentile according to the height and age)
Timepoint [1] 276998 0
During hospital admission until discharge.
Secondary outcome [2] 276999 0
To determine the need of additional anti-hypertensive (i.e: Frusemide) in conjunction with the tested anti-hypertensive in controlling the blood pressure.
Timepoint [2] 276999 0
During hospital admission until discharge
Secondary outcome [3] 277000 0
To assess the changes in the renal functions occurring in both of the tested group
Timepoint [3] 277000 0
During hospital admission until discharge
Secondary outcome [4] 279280 0
Determine the total duration of Captopril and Nifedipine used and the total duration of hospital stay in each Captopril and Nifedipine.
Timepoint [4] 279280 0
During hospital admission until discharge
Secondary outcome [5] 279281 0
To determine the duration needed for blood pressure control (i.e Systolic and Diastolic Blood Pressure of <95 percentile according to the height and age), by means of medical equipment and clinically.
Timepoint [5] 279281 0
During hospital admission until discharge
Secondary outcome [6] 279282 0
To determine of the total duration of Captopril and Nifedipie used, by means of clinical evaluation.
Timepoint [6] 279282 0
During hospital admission until discharge
Secondary outcome [7] 279283 0
To determine the duration of hospital stay in each Captopril and Nifedipine, by clinical evaluation.
Timepoint [7] 279283 0
During hospital admission until discharge
Secondary outcome [8] 279284 0
To determine the need of additional anti-hypertensive (i.e: Frusemide) in conjunction with the tested anti-hypertensive in controlling the blood pressure by means of clinical evaluation.
Timepoint [8] 279284 0
Nil
Secondary outcome [9] 279285 0
To assess the changes of renal function occurring in both of the tested group, by means of laboratory test.
Timepoint [9] 279285 0
Before treatment and at the third day after treatment.

Eligibility
Key inclusion criteria
All patients with clinical signs and symptoms PSAGN with hypertension (Blood Pressure of > 95 percentile of their respective height, age and gender) with the age between 1 year old to 12 years old, weight of 10 kg to 50 kg.
Clinical sign and symptoms of PSAGN includes history and clinical findings of facial puffiness and hematuria (urine RBC detected), decreased urine output or symptomatic hypertension. It preceded with history of impetigo or pharyngitis. Blood investigations includes complement levels, throat swab, positive ASOT or anti-DNAase.
Minimum age
1 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)Patients non post-streptococcal AGN i.e: SLE with Lupus Nephritis, Nephrotic syndrome, etc
2)Patients with PSAGN without hypertension (defined as BP > 95 percentile according to height, age and gender).
3)Encephalopathic patients defined as having seizures, severe headache and having fundoscopy changes that needs urgent antihypertensive or intravenous antihypertensives.
4)Second episode of PSAGN with hypertension.
5)Other causes of elevated BP i.e Essential Hypertension, Phaeochromocytoma
6)Patients with known renal problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3699 0
Malaysia
State/province [1] 3699 0
Kelantan

Funding & Sponsors
Funding source category [1] 267471 0
University
Name [1] 267471 0
Universiti Sains Malaysia (USM)
Country [1] 267471 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia (USM)
Address
Health Campus,
Jalan Raja Perempuan Zainab II,
Kubang Kerian, 16150
Kota Bharu, Kelantan
Country
Malaysia
Secondary sponsor category [1] 266515 0
None
Name [1] 266515 0
Address [1] 266515 0
Country [1] 266515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269448 0
The Research Ethics Committee (Human), Universiti Sains Malaysia
Ethics committee address [1] 269448 0
Ethics committee country [1] 269448 0
Malaysia
Date submitted for ethics approval [1] 269448 0
02/08/2010
Approval date [1] 269448 0
23/11/2010
Ethics approval number [1] 269448 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32834 0
Address 32834 0
Country 32834 0
Phone 32834 0
Fax 32834 0
Email 32834 0
Contact person for public queries
Name 16081 0
Aznor Fadly Bin Azim
Address 16081 0
Jabatan Pediatrik, Tingkat 6,
Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab II,
Kubang Kerian, 16150,
Kota Bharu, Kelantan
Country 16081 0
Malaysia
Phone 16081 0
+60163906285
Fax 16081 0
Email 16081 0
aznor_atid@yahoo.com
Contact person for scientific queries
Name 7009 0
Mohammad Ikram bin Ilias
Address 7009 0
Jabatan Pediatrik, Tingkat 6,
Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab II,
Kubang Kerian, 16150,
Kota Bharu, Kelantan
Country 7009 0
Malaysia
Phone 7009 0
+60199115628
Fax 7009 0
Email 7009 0
drikram@kk.usm.my

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised control trial of nifedipine versus captopril for the treatment of hypertension in children with acute post-streptococcal glomerulonephritis.2020
N.B. These documents automatically identified may not have been verified by the study sponsor.