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Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00430950
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : April 20, 2009
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners.

First patient in: 05 December 2006 Last patient out: 07 May 2008


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Trial is 2 week taper-off phase and 2 treatment periods. Period I - 8-week open-label OM 40mg. Only non-responders eligible to randomise into Period II. Period II - 8-week double-blind patients assigned into one of two arms. Results provided for Period II only.

Reporting Groups
  Description
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo

Participant Flow:   Overall Study
    OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo   OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
STARTED   502   508 
COMPLETED   489   495 
NOT COMPLETED   13   13 
Adverse Event                7                6 
Withdrawal by Subject                1                0 
concomitant medication,etc.                5                7 



  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
OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
Total Total of all reporting groups

Baseline Measures
   OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo   OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 502   508   1010 
Age, Customized 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   404   422   826 
>=65 years   93   75   168 
>= 75 years   5   11   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.7  (9.67)   54.4  (9.77)   54.6  (9.72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      194  38.6%      201  39.6%      395  39.1% 
Male      308  61.4%      307  60.4%      615  60.9% 
Race/Ethnicity, Customized 
[Units: Participants]
     
European   502   508   1010 


  Outcome Measures

1.  Primary:   Change in Mean Trough Sitting Diastolic Blood Pressure   [ Time Frame: 8 weeks ]

2.  Secondary:   Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12   [ Time Frame: 4 weeks ]

3.  Secondary:   Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.   [ Time Frame: 8 weeks ]

4.  Secondary:   Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.   [ Time Frame: 8 weeks ]

5.  Secondary:   Number of Participants Achieving Blood Pressure Goal.   [ Time Frame: 8 weeks ]


  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: Global Clinical Leader
Organization: Daiichi Sankyo
phone: 908-992-6400
e-mail: DataSharing@dsi.com


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

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00430950     History of Changes
Other Study ID Numbers: CS866CM-B-E302
First Submitted: February 1, 2007
First Posted: February 2, 2007
Results First Submitted: February 9, 2009
Results First Posted: April 20, 2009
Last Update Posted: October 12, 2017