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Trial record 17 of 134 for:    OLMESARTAN

Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension (OLMETREAT)

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ClinicalTrials.gov Identifier: NCT00311155
Recruitment Status : Completed
First Posted : April 5, 2006
Results First Posted : November 10, 2010
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Essential Hypertension
Intervention Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Enrollment 694
Recruitment Details The trial was conducted between April 2006 and April 2008 in 9 European countries at 58 investigational sites. The countries participating were: Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Switzerland, and United Kingdom.
Pre-assignment Details  
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
Period Title: Overall Study
Started 694
Completed 601 [1]
Not Completed 93
Reason Not Completed
Adverse Event             21
Withdrawal by Subject             17
Did not meet entry criteria             55
[1]
Some participants had multiple reasons for discontinuation
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
Overall Number of Baseline Participants 694
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 694 participants
58.16  (12.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 694 participants
Female
337
  48.6%
Male
357
  51.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 694 participants
Portugal 12
France 121
Belgium 94
Austria 35
Netherlands 43
Germany 207
United Kingdom 141
Italy 35
Switzerland 6
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 694 participants
82.16  (16.09)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 694 participants
28.86  (4.69)
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 694 participants
Caucasian 678
Black 13
Asian 3
1.Primary Outcome
Title The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
Hide Description For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.
Time Frame Baseline to ≤20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description:
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Overall Number of Participants Analyzed 691
Measure Type: Number
Unit of Measure: Percentage of participants
Overall N=691 71.8
OLM 20 mg N=688 12.3
OLM 20 mg+HCTZ 12.5 mg N=580 16.4
OLM 20 mg+HCTZ 25 mg N=446 19.2
OLM 20 mg+HCTZ 25 mg+AML 5 mg N=296 14.9
OLM 20 mg+HCTZ 25 mg+AML 10 mg N=176 8.5
2.Secondary Outcome
Title Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Hide Description Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.
Time Frame Baseline to ≤20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description:
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Overall Number of Participants Analyzed 691
Measure Type: Number
Unit of Measure: Percentage of participants
Overall N=691 84.5
OLM 20 mg N=688 22.7
OLM 20 mg + HCTZ 12.5 mg N=580 31.1
OLM 20 mg + HCTZ 25 mg N=446 32.7
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296 23.9
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176 14.8
3.Secondary Outcome
Title Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
Hide Description Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.
Time Frame Baseline to ≤20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description:
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Overall Number of Participants Analyzed 691
Measure Type: Number
Unit of Measure: Percentage of participants
Overall N=691 93.3
OLM 20 mg N=688 36.6
OLM 20 mg + HCTZ 12.5 mg N=580 52.4
OLM 20 mg + HCTZ 25 mg N=446 48.6
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296 33.4
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176 20.4
4.Secondary Outcome
Title Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Hide Description Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough
Time Frame Baseline to ≤20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description:
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Overall Number of Participants Analyzed 691
Measure Type: Number
Unit of Measure: Percentage of Participants
Overall N=691 92.6
OLM 20 mg N=688 34.2
OLM 20 mg + HCTZ 12.5 mg N=580 49.6
OLM 20 mg + HCTZ 25 mg N=446 46.6
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296 33.3
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176 20.5
5.Secondary Outcome
Title Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Hide Description [Not Specified]
Time Frame Baseline to ≤20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description:
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Overall Number of Participants Analyzed 691
Mean (Standard Deviation)
Unit of Measure: mm Hg
Overall N=691 -15.73  (7.98)
OLM 20 mg N=688 -6.44  (7.53)
OLM 20 mg + HCTZ 12.5 mg N=580 -10.15  (7.54)
OLM 20 mg + HCTZ 25 mg N=446 -13.04  (7.67)
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296 -14.03  (8.27)
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176 -14.47  (8.86)
6.Secondary Outcome
Title Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Hide Description [Not Specified]
Time Frame Baseline to ≤20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description:
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
Overall Number of Participants Analyzed 691
Mean (Standard Deviation)
Unit of Measure: mm Hg
Overall N=691 -29.58  (13.52)
OLM 20 mg N=688 -11.97  (11.42)
OLM 20 mg + HCTZ 12.5 mg N=580 -19.55  (12.12)
OLM 20 mg + HCTZ 25 mg N=446 -24.51  (13.14)
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296 -27.06  (13.72)
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176 -28.02  (13.52)
Time Frame The time frame was from baseline to up to 20 weeks of treatment
Adverse Event Reporting Description Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
 
Arm/Group Title Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Hide Arm/Group Description Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
All-Cause Mortality
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Affected / at Risk (%)
Total   7/694 (1.01%) 
Cardiac disorders   
Acute myocardial infarction  1  1/694 (0.14%) 
Myocardial infacrtion  1  1/694 (0.14%) 
Gastrointestinal disorders   
Inguinal hernia  1  1/694 (0.14%) 
Infections and infestations   
Cellulitis  1  1/694 (0.14%) 
Musculoskeletal and connective tissue disorders   
Spinal osteoarthritis  1  1/694 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Renal Cancer  1  1/694 (0.14%) 
Respiratory, thoracic and mediastinal disorders   
Lung disorder  1  1/694 (0.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Affected / at Risk (%)
Total   293/694 (42.22%) 
General disorders   
Oedema peripheral  1  32/694 (4.61%) 
Infections and infestations   
bronchitis  1  46/694 (6.63%) 
Urinary tract infection  1  26/694 (3.75%) 
Nasopharyngitis  1  17/694 (2.45%) 
Upper respiratory tract infection  1  17/694 (2.45%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  25/694 (3.60%) 
Pain in extremity  1  15/694 (2.16%) 
Nervous system disorders   
Dizziness  1  77/694 (11.10%) 
Headache  1  23/694 (3.31%) 
Respiratory, thoracic and mediastinal disorders   
cough  1  15/694 (2.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. Director, Regulatory Operations
Organization: Daiichi Sankyo Pharma Development
Phone: 732-590-5032
EMail: hmkessler@dsi.com
Layout table for additonal information
Responsible Party: Senior Manager - Study Coordination, Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00311155     History of Changes
Other Study ID Numbers: SP-OLM-03-05
2005-004659-36 ( EudraCT Number )
First Submitted: April 3, 2006
First Posted: April 5, 2006
Results First Submitted: October 12, 2010
Results First Posted: November 10, 2010
Last Update Posted: December 10, 2010