Clinical trial NCT00430950: Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Official title: Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Moderate-to-Severe Hypertension
Essential Hypertension
Combination Therapy
Fixed-Combination Dose
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
First posted: 2007-02-02
Enrollment: 1011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.


Eligibility criteria: Inclusion Criteria:

* Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)

Exclusion Criteria:

* Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
* Patients having a history of the following within the last six months:

  * myocardial infarction,
  * unstable angina pectoris,
  * percutaneous coronary intervention,
  * severe heart failure,
  * hypertensive encephalopathy, cerebrovascular accident (stroke) or
  * transient ischaemic attack.
* Patients with clinically significant abnormal laboratory values at screening.
* Patients with secondary HTN.

Primary outcomes:
measure: Change in Mean Trough Sitting Diastolic Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
timeFrame: 4 weeks
measure: Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
timeFrame: 8 weeks
measure: Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
timeFrame: 8 weeks
measure: Number of Participants Achieving Blood Pressure Goal.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Drongen
country: Belgium
city: Godinne
country: Belgium
city: Mouscron
country: Belgium
city: Wetteren
country: Belgium
city: Berlin
country: Germany
city: Dortmund
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Goch
country: Germany
city: Hamburg
country: Germany
city: Kallstadt
country: Germany
city: Karlsruhe
country: Germany
city: Kassel
country: Germany
city: Magdeburg
country: Germany
city: Marburg
country: Germany
city: Muenchen
country: Germany
city: Wiesbaden
country: Germany
city: Wuppertal
country: Germany
city: Alphen aan den Rijn
country: Netherlands
city: Amsterdam Zuidoost
country: Netherlands
city: Andijk
country: Netherlands
city: De Bilt
country: Netherlands
city: Den Bosch
country: Netherlands
city: Den Haag
country: Netherlands
city: Ewijk
country: Netherlands
city: Heerlen
country: Netherlands
city: Hengelo
country: Netherlands
city: Landgraaf
country: Netherlands
city: Nijmegen
country: Netherlands
city: Oud-Beijerland
country: Netherlands
city: Ridderkerk
country: Netherlands
city: Wildervank
country: Netherlands
city: Zwijndrecht
country: Netherlands
city: Bratislava
country: Slovakia
city: Levice
country: Slovakia
city: Lucenec
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Zamky
country: Slovakia
city: Vrable
country: Slovakia
Study officials:
affiliation: University of Ruhr-Bochum
name: Professor Lars Christian Rump, M.D.
role: STUDY_CHAIR
References:
citation: Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.