MK0954A-264 Filter Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00307060

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 III

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:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure Potassium

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium

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

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:

Gleim GW, Rubino J, Zhang H, Shahinfar S, Soffer BA, Lyle PA, Littlejohn TW 3rd, Feig PU. A multicenter, randomized, double-blind, parallel-group trial of the antihypertensive efficacy and tolerability of a combination of once-daily losartan 100 mg/hydrochlorothiazide 12.5 mg compared with losartan 100-mg monotherapy in the treatment of mild to severe essential hypertension. Clin Ther. 2006 Oct;28(10):1639-48.

ClinicalTrials.gov Identifier:	NCT00307060 History of Changes
Other Study ID Numbers:	2006_019
Study First Received:	March 23, 2006
Last Updated:	October 9, 2007
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 February 09, 2012