Olmesartan in Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185172
• Other study ID #: SP-OLM-01-00
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 28, 2008
• Start date: January 2002
• Est. completion date: June 2005

Study information

• Verified date: April 2008
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To test the efficacy and safety of olmesartan in patients with essential hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2333
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18 (19 if required by local authorities) to 75 years

• Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized

• Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg

• Written Informed Consent

• Mentally competent

• Negative pregnancy test in women at a childbearing age at the beginning of the study

Exclusion Criteria:

• Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension

• Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months

• Patients with a history or current evidence of congestive heart failure

• Bilateral renal artery stenosis

• Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)

• Severe hepatic impairment or biliary obstruction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Other:
• placebo
Placebo oral tablets for 2 weeks

Drug:
• olmesartan medoxomil
olmesartan medoxomil oral tablets for 8 weeks
• olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets

Locations

Country	Name	City	State
Austria	Result Cro	Wien
Germany	INPUT GmbG	Aachen
Italy	Biokos Farma s.r.l.	Bologna
Netherlands	IMRO TRAMARKO International bv	Berghem
Portugal	EUROTRIALS Lda	Lisboa
Spain	Phidea S.L.	Madrid
Switzerland	PFC Pharma Focus Consultants AG	Zurich	Volketswil
United Kingdom	Inveresk Ltd.	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Sankyo Pharma Gmbh

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.		From week 8 to week 12	No
Secondary	To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.		12 weeks	No
Secondary	To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.		12 weeks	No