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OpenTrials
Completed

NCT Number: NCT00307060

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

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.

Completed

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Key information

Conditions

Mild to Severe Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 6 weeks

Drug

losartan / Duration of Treatment: 6 weeks

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Mar 27, 2006
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.