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Trial record 52 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00886600
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : July 14, 2009
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: losartan potassium
Drug: Comparator: placebo
Drug: hydrochlorothiazide (HCTZ)
Enrollment 122
Recruitment Details Patients were recruited at 9 sites in the United States. Prime Therapy Period: May, 1991 to March, 1992.
Pre-assignment Details 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.
Arm/Group Title Placebo / HCTZ 12.5 mg Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Hide Arm/Group Description

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

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

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

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

Period Title: Double-blind Monotherapy
Started 32 29 30 31
Completed 30 28 [1] 29 29
Not Completed 2 1 1 2
Reason Not Completed
Adverse Event             1             1             1             1
Protocol Violation             0             0             0             1
Withdrawal by Subject             1             0             0             0
[1]
1 pt discontinued after Wk 4 due to AE starting in placebo baseline and continuing into double-blind
Period Title: Combination Therapy Period
Started 28 [1] 21 [2] 21 [3] 23 [4]
Completed 28 21 19 23
Not Completed 0 0 2 0
Reason Not Completed
Adverse Event             0             0             1             0
Protocol Violation             0             0             1             0
[1]
Patients did not continue from monotherapy period : 2-(Sitting Diastolic Blood Pressure (SiDBP) <85)
[2]
Patients did not continue from monotherapy period : 4-(SiDBP <85); 3-(SiDBP ≥85)
[3]
Patients did not continue from monotherapy period : 7-(SiDBP <85); 1-(SiDBP ≥85)
[4]
Patients did not continue from monotherapy period : 5-(SiDBP <85); 1-(SiDBP ≥85)
Arm/Group Title Placebo / HCTZ 12.5 mg Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 50 mg b.i.d. / HCTZ 12.5 mg Total
Hide Arm/Group Description 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 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 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 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 Total of all reporting groups
Overall Number of Baseline Participants 32 29 30 31 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 29 participants 30 participants 31 participants 122 participants
52.2  (12.0) 56.8  (12.1) 51.2  (9.6) 54.1  (9.0) 53.5  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 29 participants 30 participants 31 participants 122 participants
Female
7
  21.9%
10
  34.5%
9
  30.0%
13
  41.9%
39
  32.0%
Male
25
  78.1%
19
  65.5%
21
  70.0%
18
  58.1%
83
  68.0%
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 29 participants 30 participants 31 participants 122 participants
Caucasian 30 29 30 30 119
Oriental 0 0 0 1 1
Filipino 1 0 0 0 1
Indian 1 0 0 0 1
Diastolic 24-hr mean ambulatory blood pressure monitoring (ABPM)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 32 participants 29 participants 30 participants 31 participants 122 participants
94.8  (5.9) 94.0  (6.9) 93.8  (6.0) 94.4  (6.9) 94.2  (6.4)
Sitting Diastolic Blood Pressure (SiDBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 32 participants 29 participants 30 participants 31 participants 122 participants
100.7  (4.0) 100.0  (4.6) 101.5  (5.1) 101.2  (4.8) 100.9  (4.6)
1.Primary Outcome
Title Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Hide Description [Not Specified]
Time Frame 24 hour period at Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / HCTZ 12.5 mg Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Hide Arm/Group Description:
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
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
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
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
Overall Number of Participants Analyzed 26 28 28 30
Mean (Standard Deviation)
Unit of Measure: mm Hg
-0.2  (4.8) -5.2  (5.1) -6.4  (5.5) -8.5  (6.7)
2.Primary Outcome
Title Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Hide Description [Not Specified]
Time Frame 24-hour period at baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / HCTZ 12.5 mg Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Hide Arm/Group Description:
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
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
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
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
Overall Number of Participants Analyzed 26 28 28 30
Mean (Standard Deviation)
Unit of Measure: mm Hg
0  (7.8) -9.2  (9.9) -9.9  (7.6) -13.2  (10.6)
3.Secondary Outcome
Title Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4
Hide Description [Not Specified]
Time Frame Baseline and 24-hours after morning dose at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / HCTZ 12.5 mg Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Hide Arm/Group Description:
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
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
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
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
Overall Number of Participants Analyzed 30 29 28 30
Mean (Standard Deviation)
Unit of Measure: mm Hg
-2.1  (6.9) -6.7  (7.8) -9.6  (6.5) -8.8  (7.8)
4.Secondary Outcome
Title Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6
Hide Description [Not Specified]
Time Frame Baseline and 24-hours after morning dose at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / HCTZ 12.5 mg Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Hide Arm/Group Description:
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
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
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
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
Overall Number of Participants Analyzed 26 21 16 20
Mean (Standard Deviation)
Unit of Measure: mm Hg
-4.6  (6.1) -9.9  (6.3) -10.7  (4.9) -10.1  (7.8)
5.Secondary Outcome
Title Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6
Hide Description [Not Specified]
Time Frame Baseline and 24-hours after morning dose at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo / HCTZ 12.5 mg Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Hide Arm/Group Description:
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
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
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
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
Overall Number of Participants Analyzed 26 21 16 20
Mean (Standard Deviation)
Unit of Measure: mm Hg
-4.0  (6.4) -5.1  (7.8) -4.0  (6.1) -4.0  (6.9)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00886600     History of Changes
Other Study ID Numbers: 0954-021
MK0954-021
2009_581
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: May 21, 2009
Results First Posted: July 14, 2009
Last Update Posted: August 27, 2015