Olmesartan in Essential Hypertension

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets; Other: placebo; Drug: olmesartan medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185172

SP-OLM-01-00

Details and patient eligibility

About

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

Enrollment: 2,333 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

2,333 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

2 week placebo run-in

Treatment:

Other: placebo

2

Experimental group

Description:

Olmesartan medoxomil tablets for 8 weeks

Treatment:

Drug: olmesartan medoxomil

3

Experimental group

Description:

Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks

Treatment:

Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets