Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430508
• Other study ID #: CS866CM-B-E301
• Status: Completed
• Phase: Phase 3
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2009
• 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: 972
• Est. completion date: May 2008
• Est. primary completion date: March 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 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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week
• olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
• olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
• olmesartan medoxomil/hydrochlorothiazide tablets
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily 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

Bulgaria,  Czechia,  France,  Germany,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16	Change = Week 16 - Week 8 (baseline).	8 weeks, change = week 16 - week 8
Secondary	Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.	Change = Week 12 - Week 8 (baseline).	4 weeks, change = week 12 - week 8
Secondary	Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.	Change = Week 16 - Week 8 (baseline).	8 weeks, change = week 16 - week 8
Secondary	Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.	Change = Week 12 - Week 8 (baseline).	4 weeks, change = week 12 - week 8
Secondary	Number of Patients Achieving Target Blood Pressure at Week 16	Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics	8 weeks
Secondary	Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.	Change = Week 16 - Week 8 (baseline).	8 weeks, change = week 16 - week 8
Secondary	Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.	Change = Week 16 - Week 8 (baseline).	8 weeks, change = week 16 - week 8
Secondary	Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.	Change = Week 16 - Week 8 (baseline).	8 weeks, change = week 16 - week 8