Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects with Essential Hypertension who are Inadequately Controlled on Nifedipine Gastrointestinal Therapeutic System Monotherapy

Trial information Top of page
Trial identification
Sponsor protocol code	BAY98-7106/14728
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Bayer AG
Sponsor organisation address	Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
Public contact	Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
Scientific contact	Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	28 Sep 2016
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	28 Sep 2016
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	The primary objective is to demonstrate the superior efficacy of the FDC of nifedipine GITS and candesartan cilexetil compared to nifedipine GITS monotherapy in subjects with essential hypertension not adequately controlled on nifedipine GITS alone, based on reduction of MSSBP.
Protection of trial subjects	N/A
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	28 Sep 2016
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Germany: 99999
Worldwide total number of subjects	99999
EEA total number of subjects	99999
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	0
From 65 to 84 years	99999
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
Pre-assignment
Screening details	N/A
Period 1
Period 1 title	Overall Trial (overall period)
Is this the baseline period?	Yes
Allocation method	Not applicable
Blinding used	Not blinded
Arms
Arm title	Overall Trial
Arm description	99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
Arm type	Experimental
Investigational medicinal product name	Nifedipine GITS/Candesartan Cilexetil 30/8 mg
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	NifedipineGITS/candesartan cilexetil 30/8 mg Orally, once daily in the morning
Investigational medicinal product name	Nifedipine GITS/Candesartan Cilexetil 30/16 mg
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	NifedipineGITS/candesartan cilexetil 30/16 mg Orally, once daily in the morning
Investigational medicinal product name	Nifedipine GITS 30 mg
Investigational medicinal product code
Other name
Pharmaceutical forms	Prolonged-release tablet
Routes of administration	Oral use
Dosage and administration details	Nifedipine GITS 30 mg Orally, once daily in the morning
Number of subjects in period 1 Overall Trial Started 99999 Completed 99999

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Overall Trial
Reporting group description	99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
Reporting group values Overall Trial Total Number of subjects 99999 99999 Age categorical 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial. Units: Subjects     In utero 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0     Newborns (0-27 days) 0 0     Infants and toddlers (28 days-23 months) 0 0     Children (2-11 years) 0 0     Adolescents (12-17 years) 0 0     Adults (18-64 years) 0 0     From 65-84 years 99999 99999     85 years and over 0 0 Gender categorical 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial. Units: Subjects     Female 99999 99999     Male 0 0

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Overall Trial
Reporting group description	99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.

End points Top of page

Primary: Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 8change from baseline in MSSBP at Week 8 Top of page
End point title	Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 8change from baseline in MSSBP at Week 8 [1]
End point description	99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
End point type	Primary
End point timeframe	N/A
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No subjects were enrolled in the trial. Consequently, no results are available for this trial.
End point values Overall Trial Number of subjects analysed 99999 [2] Units: Number of subjects analysed 99999
Notes [2] - No subjects were enrolled in the trial hence results are not available
No statistical analyses for this end point

Primary: Change from baseline in mean seated systolic blood pressure (MSSBP) at Week 8change from baseline in MSSBP at Week 8 Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	N/A
Adverse event reporting additional description	99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	0
Reporting groups
Reporting group title	Overall Trial
Reporting group description	99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
Serious adverse events Overall Trial Total subjects affected by serious adverse events      subjects affected / exposed 0 / 99999 (0.00%)      number of deaths (all causes) 0      number of deaths resulting from adverse events 0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events Overall Trial Total subjects affected by non serious adverse events      subjects affected / exposed 0 / 99999 (0.00%)
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: No subjects were enrolled in the trial. Consequently, no results are available for this trial.

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial. Consequently, no results are available for this trial.

More information Top of page