Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430950
• Other study ID #: CS866CM-B-E302
• Status: Completed
• Phase: Phase 3
• Start date: February 2007
• Est. completion date: October 2008

Study information

• Verified date: October 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: October 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
• olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.	Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Trough Sitting Diastolic Blood Pressure	Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.; Change = Week 16 - Week 8 (baseline).	8 weeks
Secondary	Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12	Change = Week 12 - Week 8 (baseline).	4 weeks
Secondary	Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.	4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).	8 weeks
Secondary	Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.	Change = Week 16 - Week 8 (baseline).	8 weeks
Secondary	Number of Participants Achieving Blood Pressure Goal.		8 weeks