Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection (ArtStiff)

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Hypertension; Metabolic Syndrome

Treatments: Drug: olmesartan medoxomil; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676845

2007-003131-23 EudraCT number

DSE-866/47

Details and patient eligibility

About

This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in arterial stiffness in subjects with hypertension and metabolic syndrome

Enrollment: 133 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female outpatients
• Age greater than or equal to 18 years and less than or equal to 75 years
• Hypertension and metabolic syndrome defined, according to the ATP III/IDF 2005 and ESH/ESC 2007 definitions, as BP greater than or equal to 130/85 mmHg and <150/95 mmHg (i.e. untreated high normal BP or "low range" mild hypertension) and at least 2 of the following traits at:
• Abdominal obesity (waist circumference >102 cm for men and >88 cm for women)
• Triglyceride level greater than or equal to 150 mg/dL
• High density lipoprotein (HDL) <40 mg/dL for men and <50 mg/dL for women
• Fasting blood glucose greater than or equal to 110 mg/dL and <126 mg/dL (i.e. no type 2 diabetes)
• No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. Note: treatment with angiotensin II receptor blockers (ARB)or angiotensin-converting enzyme inhibitors (ACE) is not allowed within the last 6 months.

Exclusion criteria

• Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception)
• Type 1 and type 2 diabetes
• "High range" mild hypertension (i.e. systolic blood pressure [SBP]: 150 - <160 mmHg and /or diastolic blood pressure [DBP]: 95 - <100 mmHg)
• Moderate (SBP: 160 - 179 mmHg and DBP: 100 - 109 mmHg), severe (SBP: greater than or equal to 180 mmHg and/or greater than or equal to 110 mmHg), or resistant (hypertension resistant to treatment)hypertension
• Secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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133 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

A 3-week placebo run-in period.

Treatment:

Drug: placebo

2

Experimental group

Description:

Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period

Treatment:

Drug: olmesartan medoxomil

Drug: olmesartan medoxomil

Drug: olmesartan medoxomil

3

Experimental group

Description:

Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.

Treatment:

Drug: olmesartan medoxomil

Drug: olmesartan medoxomil

Drug: olmesartan medoxomil

4

Experimental group

Description:

Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 4 weeks followed by the highest study dose for 44 weeks.

Treatment:

Drug: olmesartan medoxomil

Drug: olmesartan medoxomil

Drug: olmesartan medoxomil