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| ID | Type | Description | Link |
|---|---|---|---|
| MK0954-021 | |||
| 2009_581 |
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The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
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| 2 | Experimental | losartan 50 mg q.d. |
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| 3 | Experimental | losartan 100 mg q.d. |
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| 4 | Experimental | losartan 50 mg b.i.d. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan potassium | Drug | losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 | 24 hour period at Baseline and Week 4 | |
| Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 | 24-hour period at baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4 | Baseline and 24-hours after morning dose at Week 4 | |
| Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7848024 | Background | Weber MA, Byyny RL, Pratt JH, Faison EP, Snavely DB, Goldberg AI, Nelson EB. Blood pressure effects of the angiotensin II receptor blocker, losartan. Arch Intern Med. 1995 Feb 27;155(4):405-11. |
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Patients could be randomized if sitting diastolic blood pressure (SiDBP) after 2 and 4 weeks of placebo washout was 95-115 mm Hg and the difference between measurements at the 2 visits was ≤7 mm Hg. At the end of placebo baseline the mean 24-hr DBP using ambulatory blood pressure monitoring (ABPM) had to be at least 85 mm Hg.
Patients were recruited at 9 sites in the United States. Prime Therapy Period: May, 1991 to March, 1992.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo / HCTZ 12.5 mg | Double-blind Monotherapy: Losartan placebo orally once daily for 4 weeks Combination Therapy Period: Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Monotherapy |
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| Comparator: placebo | Drug | placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks |
|
| hydrochlorothiazide (HCTZ) | Drug | open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks |
|
|
| Baseline and 24-hours after morning dose at Week 6 |
| Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6 | Baseline and 24-hours after morning dose at Week 6 |
| Losartan 50 mg q.d. / HCTZ 12.5 mg |
Double-blind Monotherapy: Losartan 50 mg orally once daily (q.d.) for 4 weeks Combination Therapy Period: Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks |
| FG002 | Losartan 100 mg q.d. / HCTZ 12.5 mg | Double-blind Monotherapy: Losartan 100 mg orally once daily (q.d.) for 4 weeks Combination Therapy Period:Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy).orally once daily for 2 weeks |
| FG003 | Losartan 50 mg b.i.d. / HCTZ 12.5 mg | Double-blind Monotherapy: Losartan 50 mg orally twice daily (b.i.d.) for 4 weeks Combination Therapy Period: Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| Combination Therapy Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo / HCTZ 12.5 mg | Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks |
| BG001 | Losartan 50 mg q.d. / HCTZ 12.5 mg | Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks |
| BG002 | Losartan 100 mg q.d. / HCTZ 12.5 mg | Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks |
| BG003 | Losartan 50 mg b.i.d. / HCTZ 12.5 mg | Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity | Number | participants |
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| Diastolic 24-hr mean ambulatory blood pressure monitoring (ABPM) | Mean | Standard Deviation | mm Hg |
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| Sitting Diastolic Blood Pressure (SiDBP) | Mean | Standard Deviation | mm Hg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 | The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | 24 hour period at Baseline and Week 4 |
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| Primary | Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 | The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | 24-hour period at baseline and Week 4 |
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| Secondary | Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4 | The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 24-hours after morning dose at Week 4 |
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| Secondary | Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6 | The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 24-hours after morning dose at Week 6 |
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| Secondary | Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6 | The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 24-hours after morning dose at Week 6 |
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Safety has been reported in the literature.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Protocol Violation |
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| Male |
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| Oriental |
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| Filipino |
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| Indian |
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Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
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Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks |
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Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks |
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Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks |
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