Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00095550 |
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Recruitment Status :
Completed
First Posted : November 8, 2004
Last Update Posted : April 15, 2011
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Drug: Irbesartan/HCTZ Drug: Irbesartan monotherapy Drug: HCTZ monotherapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 496 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension |
| Study Start Date : | October 2004 |
| Actual Primary Completion Date : | June 2005 |
| Actual Study Completion Date : | June 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
Drug Information available for:
Irbesartan
| Arm | Intervention/treatment |
|---|---|
| Experimental: A1 |
Drug: Irbesartan/HCTZ
Tablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
Other Name: Avapro |
| Active Comparator: A2 |
Drug: Irbesartan monotherapy
Tablets, Oral, 150 mg, Once daily, 12 weeks.
Other Name: Avapro |
| Active Comparator: A3 |
Drug: HCTZ monotherapy
Tablets, Oral, 12.5 mg, Once daily, 12 weeks. |
Primary Outcome Measures :
- Change from baseline in SeSBP at Week 8
Secondary Outcome Measures :
- Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Willing to provide written informed consent
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095550
Locations
Show 128 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00095550 |
| Other Study ID Numbers: |
CV131-185 |
| First Posted: | November 8, 2004 Key Record Dates |
| Last Update Posted: | April 15, 2011 |
| Last Verified: | August 2008 |
Keywords provided by Bristol-Myers Squibb:
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Moderate Hypertension |
Additional relevant MeSH terms:
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Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Irbesartan Antihypertensive Agents Diuretics |
Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |