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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00400218
First received: November 15, 2006
Last updated: May 23, 2013
Last verified: May 2013
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400218

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Losartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014