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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Irbesartan monotherapy; Drug: HCTZ monotherapy; Drug: Irbesartan/HCTZ

• Registration Number: NCT00095550
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-11-05
• Study First Submitted QC: 2004-11-05
• Study First Posted: 2004-11-08
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2008-08
• Disposition First Submitted: 2010-02-15
• Disposition First Submitted QC: 2010-02-15
• Disposition First Posted: 2010-02-17
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Irbesartan monotherapy	-
A3	HCTZ monotherapy	-
A1	Irbesartan/HCTZ	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in SeSBP at Week 8

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇷🇺 St. Petersburg, Russian Federation