Clinical trial NCT00430508: Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Official title: Efficacy and Safety of Hydrochlorothiazide (HCTZ) Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil (OM) 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: 972
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 hypertension (HTN)

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 From Week 8(Baseline) to Week 16
timeFrame: 8 weeks, change = week 16 - week 8
Secondary outcomes:
measure: Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
timeFrame: 4 weeks, change = week 12 - week 8
measure: Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
timeFrame: 8 weeks, change = week 16 - week 8
measure: Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
timeFrame: 4 weeks, change = week 12 - week 8
measure: Number of Patients Achieving Target Blood Pressure at Week 16
timeFrame: 8 weeks
measure: Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
timeFrame: 8 weeks, change = week 16 - week 8
measure: Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
timeFrame: 8 weeks, change = week 16 - week 8
measure: Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
timeFrame: 8 weeks, change = week 16 - week 8
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Beroun
country: Czechia
city: Brno
country: Czechia
city: Chrudim
country: Czechia
city: Hradec Kralove
country: Czechia
city: Jindrichuv Hradec
country: Czechia
city: Kutna Hora
country: Czechia
city: Ostrava
country: Czechia
city: Pardubice
country: Czechia
city: Plzen
country: Czechia
city: Prague
country: Czechia
city: Pribram
country: Czechia
city: Revnice
country: Czechia
city: Sokolov
country: Czechia
city: Trutnov
country: Czechia
city: Langres
country: France
city: Paris
country: France
city: Pessac
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dietzenbach
country: Germany
city: Franfurt
country: Germany
city: Friedberg
country: Germany
city: Ingelheim
country: Germany
city: Karlsbad
country: Germany
city: Leipzig
country: Germany
city: Offenbach
country: Germany
city: Siegen
country: Germany
city: Stuhr-Brinkum
country: Germany
city: Elblag
country: Poland
city: Gdansk
country: Poland
city: Inowroclaw
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Linia
country: Poland
city: Lodz
country: Poland
city: Olawa
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zamosc
country: Poland
city: Girona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhya
country: Ukraine
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.