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OpenTrials
Completed

NCT Number: NCT00185172

Olmesartan in Essential Hypertension

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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Result Cro, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Placebo oral tablets for 2 weeks

olmesartan medoxomil

Drug

olmesartan medoxomil oral tablets for 8 weeks

olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets

Drug

olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets

Primary outcomes

  1. 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.

    Time frame: From week 8 to week 12

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Sankyo Pharma Gmbh

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Apr 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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