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Trial record 15 of 134 for:    OLMESARTAN

Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension (Benibest)

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ClinicalTrials.gov Identifier: NCT00890591
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : April 30, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design 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 144
Recruitment Details The study pop. was defined by the inclusion criteria. This study was carried out in 14 centers in Brazil with inclusion 2 months after the first study subject, started in Aug 06. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. The last patient out was in Jul 07.
Pre-assignment Details A wash out period was needed in case of a previous inefficient antihypertensive medication, so it was interrupted from 2 to 3 wks before the enrollment. The patient could be excluded considering the exclusion criteria.
Arm/Group Title Olmesartan + Hydrochlorothiazide + Amlodipine
Hide Arm/Group Description
  1. olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.
  2. olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved
  3. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved
  4. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved
Period Title: Overall Study
Started 144
Completed 124
Not Completed 20
Reason Not Completed
Lack of Efficacy             20
Arm/Group Title Olmesartan + Hydrochlorothiazide + Amlodipine
Hide Arm/Group Description
  1. olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.
  2. olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved
  3. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved
  4. olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved
Overall Number of Baseline Participants 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
<=18 years
0
   0.0%
Between 18 and 65 years
132
  91.7%
>=65 years
12
   8.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
Female
74
  51.4%
Male
70
  48.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 144 participants
Black 24
White 83
Asian 7
Other 30
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 144 participants
144
1.Primary Outcome
Title Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)
Hide Description Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level
Time Frame 4 - 9 wks of olmesartan monotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
In this first dosage group 144 started and 38 patients met their blood pressure goal; therefore, 106 started the first titration regimen. There were no dropouts.
Arm/Group Title Olmesartan Monotherapy
Hide Arm/Group Description:
olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
Overall Number of Participants Analyzed 144
Measure Type: Number
Unit of Measure: Participants
38
2.Primary Outcome
Title Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)
Hide Description Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks
Time Frame 4 to 9 weeks on combination therapy
Hide Outcome Measure Data
Hide Analysis Population Description
In this first titration group 106 patients started and 33 achieved their blood pressure goal. There were no dropouts and 73 subject started the second titration regimen.
Arm/Group Title Olmesartan + Hydrochlorothiazide
Hide Arm/Group Description:
olmesartan 20 mg/hydrochlorothiazide 12.5 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: Participants
33
3.Primary Outcome
Title Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)
Hide Description Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.
Time Frame 4 to 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
73 patients started the second titration regimen and 41 met their blood pressure goal. There were no dropouts. 32 started the final titration regimen.
Arm/Group Title Olmesartan + Hydrochlorothiazide
Hide Arm/Group Description:
olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: Participants
41
4.Primary Outcome
Title Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)
Hide Description Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.
Time Frame 4 - 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
32 subjects started the third and final titration regimen and 12 met their blood pressure goals. 20 dropped out for lack of efficacy.
Arm/Group Title Olmesartan + Hydrochlorothiazide + Amlodipine
Hide Arm/Group Description:
olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets + amlodipine tablets 5 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Participants
12
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: Howard Kessler
Organization: Daiichi Sankyo Pharma Development
Phone: 732-590-5032
EMail: hmkessler@dsus.com
Layout table for additonal information
Responsible Party: Medical Affairs Manager, Daiichi Sankyo Brazil
ClinicalTrials.gov Identifier: NCT00890591     History of Changes
Other Study ID Numbers: SPB-OM-0106
First Submitted: February 11, 2009
First Posted: April 30, 2009
Results First Submitted: February 11, 2009
Results First Posted: April 30, 2009
Last Update Posted: June 3, 2009