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Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

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ClinicalTrials.gov Identifier: NCT00926289
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : May 24, 2011
Last Update Posted : June 27, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Telmisartan
Drug: Hydrochlorothiazide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
894 patients were entered (randomised) into the study; however, of these, 6 were not treated. Therefore 888 patients actually entered into treatment.

Reporting Groups
  Description
Telmisartan 40/80 mg Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Participant Flow:   Overall Study
    Telmisartan 40/80 mg   Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg
STARTED   294 [1]   594 [1] 
COMPLETED   269   558 
NOT COMPLETED   25   36 
Adverse Event                9                11 
Protocol Violation                8                12 
Lost to Follow-up                3                6 
Withdrawal by Subject                4                4 
not specified                1                3 
[1] Number of treated patients



  Baseline Characteristics

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
Telmisartan 40/80 mg Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
Telmisartan 40/80 mg + HCTZ 12.5/25 mg fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Total Total of all reporting groups

Baseline Measures
   Telmisartan 40/80 mg   Telmisartan 40/80 mg + HCTZ 12.5/25 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 294   594   888 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (11.9)   56.8  (11.3)   57.0  (11.5) 
Gender 
[Units: Participants]
     
Female   125   285   410 
Male   169   309   478 


  Outcome Measures

1.  Primary:   Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7   [ Time Frame: Baseline and Week 7 ]

2.  Secondary:   Change From Baseline in Mean Seated Trough Cuff SBP to Week 5   [ Time Frame: Baseline and Week 5 ]

3.  Secondary:   Change From Baseline in Mean Seated Trough Cuff SBP to Week 3   [ Time Frame: Baseline and Week 3 ]

4.  Secondary:   Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7   [ Time Frame: Baseline and Week 7 ]

5.  Secondary:   Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7   [ Time Frame: Week 7 timepoint ]

6.  Secondary:   Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5   [ Time Frame: Week 5 timepoint ]

7.  Secondary:   Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3   [ Time Frame: Week 3 timepoint ]

8.  Secondary:   Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7   [ Time Frame: Week 7 timepoint ]

9.  Secondary:   Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5   [ Time Frame: Week 5 timepoint ]

10.  Secondary:   Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3   [ Time Frame: Week 3 timepoint ]

11.  Secondary:   Number of Patients With Blood Pressure (BP) Control at Week 7   [ Time Frame: Week 7 timepoint ]

12.  Secondary:   Number of Patients With BP Control at Week 7   [ Time Frame: Week 7 timepoint ]

13.  Secondary:   Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7   [ Time Frame: Week 7 timepoint ]

14.  Secondary:   Number of Participants With DBP Response at Week 7   [ Time Frame: Week 7 timepoint ]

15.  Secondary:   BP Categories at Week 7   [ Time Frame: Week 7 timepoint ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00926289     History of Changes
Other Study ID Numbers: 502.550
2008-007711-32 ( EudraCT Number: EudraCT )
First Submitted: June 22, 2009
First Posted: June 23, 2009
Results First Submitted: April 20, 2011
Results First Posted: May 24, 2011
Last Update Posted: June 27, 2014