Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension
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|ClinicalTrials.gov Identifier: NCT00095550|
Recruitment Status : Completed
First Posted : November 8, 2004
Last Update Posted : April 15, 2011
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
- Change from baseline in SeSBP at Week 8
- Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.
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
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|