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Evaluate the Safety and Anti-Hypertensive Efficacy of Hyzaar(R) In Patients With Mild To Moderate Essential Hypertension (0954A-323)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00400218
First received: November 15, 2006
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to moderate essential hypertension.


Condition Intervention Phase
Hypertension
 Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluate the Safety and Tolerability of Hyzaar(R) (Losartan 50 Mg/ Hydrochlorothiazide 12.5 Mg) In the Treatment of Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Blood pressure over 12 weeks
  • Safety and Tolerability.

Estimated Enrollment: 30
Study Start Date: September 2005
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is either receiving high blood pressure monotherapy or no treatment
  • Patient will have reached the legal age by the time enter the study
  • Patients diagnosed with mild to moderate essential high blood pressure or high blood pressure with other conditions such as diabetes or cardiovascular diseases and are taking high blood pressure medication (exclude diuretic), but did not meet treatment goal

Exclusion Criteria:

  • Patient with high levels of uric acid in the blood who has received medications for uric acid in the urine within 3 months prior to enrollment
  • Patients who are hypersensitive to any component of the study medication
  • Patients who are hypersensitive to other sulfonamide-derived drugs
  • Patients with anuria (hyzaar(R) is not recommended for patients with hepatic impairment or severe renal impairment, creatinine clearance </= 30 ml/min)
  • Unstable diabetes (hba1c > 8%), or a change in diabetes medication during study treatment. patients with stable diabetes may enter the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400218

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00400218     History of Changes
Other Study ID Numbers: 2006_049, MK0954A-323
Study First Received: November 15, 2006
Last Updated: May 23, 2013
Health Authority: Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 18, 2013