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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400218
First Posted: November 16, 2006
Last Update Posted: April 28, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 62
Actual Study Start Date: September 1, 2005
Study Completion Date: July 19, 2006
Primary Completion Date: July 1, 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00400218


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00400218     History of Changes
Other Study ID Numbers: 0954A-323
2006_049
First Submitted: November 15, 2006
First Posted: November 16, 2006
Last Update Posted: April 28, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Antihypertensive Agents
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