Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01788358
First received: February 7, 2013
Last updated: August 19, 2015
Last verified: August 2015
Results First Received: July 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 70 study centers between 14 February 2013 (first subject first visit) and 1 May 2014 (last subject last visit).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 753 subjects screened, 245 subjects were not enrolled, due to screen failure for 215 subjects, consent withdrawal by 23 subjects, protocol violation by 5 subjects, 1 subject was lost to follow-up and recruitment stopped for 1 subject. Remaining 508 subjects were enrolled and received at least 1 treatment with study drug.

Reporting Groups
  Description
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).

Participant Flow:   Overall Study
    Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)  
STARTED     508  
Treated     508  
Completed Week 28     417  
Entered Extension to Week 52     200 [1]
Completed Week 52     193  
COMPLETED     410 [2]
NOT COMPLETED     98  
Unspecified                 11  
Logistical difficulties                 1  
Lost to Follow-up                 5  
Protocol Violation                 3  
Withdrawal by Subject                 26  
Lack of Efficacy                 1  
Adverse Event                 51  
[1] Only the first 200 subjects who completed Week 28 visit, continued treatment up to 52 weeks.
[2] 217 subjects completed the study at Week 28 while the remaining 193 subjects completed at Week 52



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).

Baseline Measures
    Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)  
Number of Participants  
[units: participants]
  508  
Age  
[units: years]
Mean (Standard Deviation)
  59  (10.2)  
Gender  
[units: Participants]
 
Female     186  
Male     322  
Systolic blood pressure  
[units: millimeter of mercury (mmHg)]
Mean (Standard Deviation)
  170.7  (8.9)  
Diastolic blood pressure  
[units: mmHg]
Mean (Standard Deviation)
  95.6  (10.4)  



  Outcome Measures
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1.  Primary:   Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28   [ Time Frame: From the time of first study drug administration up to Week 28 ]

2.  Primary:   Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28   [ Time Frame: From the time of first study drug administration up to Week 28 ]

3.  Primary:   Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)   [ Time Frame: From the time of first study drug administration up to Week 52/EOS ]

4.  Primary:   Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)   [ Time Frame: From the time of study treatment up to Week 52/EOS ]

5.  Secondary:   Number of Subjects With Clinically Relevant Changes in Laboratory Parameters   [ Time Frame: Baseline (Week 0) up to Week 52/EOS ]

6.  Secondary:   Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52   [ Time Frame: Baseline (Week 0), Weeks 28 and 52 ]

7.  Secondary:   Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52   [ Time Frame: Baseline (Week 0), Weeks 28 and 52 ]

8.  Secondary:   Blood Pressure Control Rate at Weeks 28 and 52   [ Time Frame: Weeks 28 and 52 ]

9.  Secondary:   Blood Pressure Response Rate at Weeks 28 and 52   [ Time Frame: Weeks 28 and 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Bayer HealthCare AG
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01788358     History of Changes
Other Study ID Numbers: 14801, 2012-004515-32
Study First Received: February 7, 2013
Results First Received: July 21, 2015
Last Updated: August 19, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration