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

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. Identifier: NCT00307060
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Actual Study Start Date : December 1, 2004
Primary Completion Date : June 1, 2005
Study Completion Date : June 2, 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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

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.

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 identifier (NCT number): NCT00307060

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

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00307060     History of Changes
Other Study ID Numbers: 0954A-264
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

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