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NCT Number: NCT00095550

Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension

The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Red Deer, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing to provide written informed consent
  • Subjects must have uncontrolled hypertension defined as:
  • average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or
  • average diastolic blood pressure between 100 mmHg and 110 mmHg (while systolic blood pressure is between 130 mmHg and 180 mmHg)
  • Subjects must be willing to discontinue their antihypertensive medication, if applicable.
  • Men and women, ages 18 and older will be included.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to one week after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication.

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • Known or suspected secondary hypertension
  • Hypertension emergencies or stroke within the past 12 months.
  • Heart attack, angina or bypass surgery within the past six months.
  • Significant kidney disease
  • Significant liver disease
  • Systemic lupus erythematosus
  • Gastrointestinal disease or surgery that interfere with drug absorption
  • Cancer during the past five years excluding localized squamous cell or basal cell carcinoma of the skin
  • Currently pregnant or lactating
  • Mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Drug or alcohol abuse within the last five years
  • Known allergy to irbesartan or diuretics

Treatment and study plan

Irbesartan/HCTZ

Drug

Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.

Other names: Avapro

Irbesartan monotherapy

Drug

Tablets, Oral, 150 mg, Once daily, 12 weeks.

Other names: Avapro

HCTZ monotherapy

Drug

Tablets, Oral, 12.5 mg, Once daily, 12 weeks.

Primary outcomes

  1. Change from baseline in SeSBP at Week 8

Secondary outcomes

  1. Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Sanofi

Registry information

Official study title

The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 8, 2004
Registry last updated
Apr 15, 2011

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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