Clinical Trial Results:
Effects of an Angiotensin Receptor Antagonist Candesartan versus a calcium channel blocker Amlodipine on Microvascular Rarefaction, Endothelial Dysfunction and Microalbuminuria in Essential Hypertension
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Summary
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EudraCT number |
2008-005432-32 |
Trial protocol |
GB |
Global end of trial date |
14 Jul 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Nov 2019
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First version publication date |
09 Nov 2019
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Other versions |
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Summary report(s) |
Effects of Candesartan versus Amlodipine on Capillary Rarefaction, Pulse Wave Velocity and Central Blood Pressure in Patients with Essential Hypertension |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
08.0113
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
St George's University of London
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Sponsor organisation address |
Cranmer Terrace, London, United Kingdom,
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Public contact |
Joint Research Office, St George's University of London, 0044 02087254986,
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Scientific contact |
Joint Research Office, St George's University of London, 0044 02087254986,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Jan 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Jul 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jul 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the effects of controlling blood pressure with candesartan 8-16 mg od versus amlodipine 5-10 mg od on microvascular capillary rarefaction in patients with mild-to-moderate essential hypertension.
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Protection of trial subjects |
Number of patients still receiving treatment at time of early termination in the MS concerned by the declaration and their proposed management; 0
The consequences of early termination for the evaluation of the results and for overall risk benefit assessment of the investigational medicinal product. There will be insufficient data collected to reach primary objective: to evaluate the effects of controlling BP with Candesartan vs Amlodipine in improving the microvascular capillary rarefaction in patients with mild to moderate essential hypertension or to answer secondary objectives of change in basal capillary density, improvement in pulse wave velocity, change in aortic augmentation index, and reduction in microalbuminuria
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Aug 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
Patients will attend the Blood Pressure Unit at St. George’s, University of London, on 4 occasions over a period of 10 weeks. Each visit will last about 30-45 minutes. At each visit we will measure blood pressure, pulse rate and body weight. | |||||||||
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Period 1
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Period 1 title |
Recruitment (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
n/a
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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arm 1 | |||||||||
Arm description |
After 2-week single-blind placebo run-in period, patients will be randomised to 8-weeks treatment with either Candesartan 8 mg od (with forced titration to 16 mg od after 2 wks) or Amlodipine 5 mg od (with forced titration to 10 mg od after 2 wks). Blood pressure will be measured in the same arm, with an automatic oscillometric sphygmo-manometer (OMRON HEM705CP) with appropriate cuff size. Sitting and standing BP will be taken as the mean of the last 2 out of 3 readings | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Candesartan
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Unknown use
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Dosage and administration details |
Candesartan 8 mg capsules
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Investigational medicinal product name |
Amlodipine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Unknown use
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Dosage and administration details |
Amlodipine 5 mg
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Arm title
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Arm 2 | |||||||||
Arm description |
Placebo lactose capsules | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
lactose
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Unknown use
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Dosage and administration details |
Placebo lactose capsules
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End points reporting groups
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Reporting group title |
arm 1
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Reporting group description |
After 2-week single-blind placebo run-in period, patients will be randomised to 8-weeks treatment with either Candesartan 8 mg od (with forced titration to 16 mg od after 2 wks) or Amlodipine 5 mg od (with forced titration to 10 mg od after 2 wks). Blood pressure will be measured in the same arm, with an automatic oscillometric sphygmo-manometer (OMRON HEM705CP) with appropriate cuff size. Sitting and standing BP will be taken as the mean of the last 2 out of 3 readings | ||
Reporting group title |
Arm 2
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Reporting group description |
Placebo lactose capsules | ||
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End point title |
The increase in maximal capillary density at the end of 8 weeks treatment | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
8 weeks treatment
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Statistical analysis title |
ANOVA | ||||||||||||
Statistical analysis description |
The study will have a power of 80% (ß= 0.20) to detect a difference of 8 in capillary density
before and after treatment at a level of significance of =0.05.
ANOVA for repeated measures and Student t Test would be used to compare maximal
capillary density before and after treatment. A level of significance of =0.05 will be used.
All measurements outlined in Section 10.3 of the protocol will be performed before
randomization, at 4 weeks and at the end of the study treatment at 8 weeks.
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Comparison groups |
arm 1 v Arm 2
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Number of subjects included in analysis |
18
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Analysis specification |
Post-hoc
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Analysis type |
other | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
All adverse events will be recorded in the hospital notes in the first instance.
A record of all AEs, whether related or unrelated to the treatment will also be kept in the
CRF and the Sponsor’s AE Log.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
SMPC | ||
Dictionary version |
1
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: n/a |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
