Official Title: “A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Factorial Study of Metoprolol Succinate Extended Release Tablets (TOPROL-XL) Hydrochlorothiazide and Their Combination in Patients With Essential Hypertension.”

The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2004

Intervention(s) in this Clinical Trial

• Drug: Metoprolol Succinate
• Drug: Hydrochlorothiazide

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Metoprolol Succinate + Hydrochlorothiazide
• Active Comparator: 2
  • Metoprolol Succinate
• Active Comparator: 3
  • Hydrochlorothiazide

Primary Measures

• Change in trough sitting diastolic blood pressure
  • Time Frame: 3 readings determined at 8 weeks after treatment
    

Secondary Measures

• change in trough Sitting Systolic Blood pressure
  • Time Frame: 3 readings determined at 8 weeks after treatment
    
• change in trough Standing Systolic Blood Pressure
  • Time Frame: 6 readings determined at 8 weeks after treatment
    
• change in trough standing diastolic blood pressure
  • Time Frame: 6 readings determined at 8 weeks after treatment
    

Inclusion Criteria:

• Diastolic blood pressure between 95 and 114 mm at screening and start of treatment

Exclusion Criteria:

• Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis
• Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism
• Systolic blood pressure greater or equal to 180 mm Hg at start of trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Vasilios Papademetriou Principal Investigator Georgetown University  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642096

Study ID Number: D4026C00001

ClinicalTrials.gov Identifier: NCT00642096

Health Authority: United States: Food and Drug Administration