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MK0954A-264 Filter Study (0954A-264)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00307060
First received: March 23, 2006
Last updated: May 24, 2013
Last verified: May 2013
History of Changes
  Purpose

To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.


Condition Intervention Phase
Mild to Severe Hypertension
 Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks
Drug: losartan / Duration of Treatment: 6 weeks
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment. [ Time Frame: 6 Weeks ]

Secondary Outcome Measures:
  • Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable. [ Time Frame: 6 Weeks ]

Estimated Enrollment: 300
Study Start Date: December 2004
Primary Completion Date: June 2005 (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:

  • Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)

Exclusion Criteria:

  • Systolic BP > 200 mmHg
  • Secondary or malignant hypertension
  • Taking more than 2 antihypertensive medications
  • Hypertension induced by oral contraceptives
  • Hx of cerebral vascular accident within 6 months
  • Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months
  • Clinically significant AV conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope
  • History of angioedema
  • Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney function
  • Pregnancy or lactation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307060

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

Publications:

ClinicalTrials.gov Identifier: NCT00307060     History of Changes
Other Study ID Numbers: 2006_019
Study First Received: March 23, 2006
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

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 17, 2013