Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome (0954A-331)

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.
 
ClinicalTrials.gov Identifier: NCT00546052
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : June 23, 2009
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypertension
Metabolic Disorder
Intervention Drug: losartan potassium (+) hydrochlorothiazide
Enrollment 1738
Recruitment Details First Patient In: 12-Sep-2005 Last Patient In: 29-Dec-2006 Last Patient Last Visit: 31-Jan-08 Total number of Sites (General Practitioners and Family Physicians in Canada): 209
Pre-assignment Details 24 patients not included in the Intention to Treat (ITT) analysis because they did not receive study medication and had no follow up visits. Total ITT population = 1714.
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
Period Title: Overall Study
Started 1738
Week 4 1714
Week 8 1680
Week 12 1650
Week 32 1583
Week 52 1511
Completed 1511
Not Completed 227
Reason Not Completed
Adverse Event             47
Lost to Follow-up             144
Protocol Violation             9
Withdrawal by Subject             20
Non Compliance             7
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
Overall Number of Baseline Participants 1714
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1714 participants
54.93  (11.29)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1714 participants
<=45.00 326
45.01 - 52.00 359
52.01 - 58.00 356
58.01 - 65.00 346
>=65.00 326
Missing 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1714 participants
Female
734
  42.8%
Male
980
  57.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1714 participants
Caucasian 1451
Black 32
Asian 200
Native American 11
Other 19
Missing 1
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 1714 participants
33.23  (5.59)
C-Reactive Protein  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 1714 participants
5.4  (8.8)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 1714 participants
90.54  (8.16)
Fasting Blood Glucose  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 1714 participants
5.7  (0.7)
Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats per Minute (BPM)
Number Analyzed 1714 participants
75  (8.0)
Hemoglobin A1c  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 1714 participants
5.71  (0.59)
High Density Lipoprotein-C  
Mean (Standard Deviation)
Unit of measure:  mol/L
Number Analyzed 1714 participants
1.23  (0.33)
Low Density Lipoprotein-C  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 1714 participants
3.17  (0.93)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 1714 participants
148.22  (10.72)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 1714 participants
5.36  (1.05)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 1714 participants
2.16  (1.16)
Uric Acid  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 1714 participants
365.8  (85.4)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (Kg)
Number Analyzed 1714 participants
92.5  (18.1)
1.Primary Outcome
Title Change in Hemoglobin A1c Between 52 Weeks and Baseline
Hide Description Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Median (Standard Deviation)
Unit of Measure: Percent
0.04  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-0.02 to 0.06
Parameter Dispersion
Type: Standard Deviation
Value: 0.74
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments
Hide Description Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.02  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5mmol/L.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
0.01 to 0.07
Parameter Dispersion
Type: Standard Deviation
Value: 0.62
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Target Blood Pressure
Hide Description Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks
Time Frame 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT and Per Protocol
Arm/Group Title Overall Total Overall Intend to Treat Overall Per Protocol
Hide Arm/Group Description:
All patients enrolled (signed the informed consent).
All patients enrolled and receiving at least one dose of study drug and having at least one follow up visit.
All patients completing the 52 week study follow up.
Overall Number of Participants Analyzed 1738 1714 1511
Measure Type: Number
Unit of Measure: Participants
Achieved Target Blood Pressure 1200 1200 1200
Did NOT achieve target Blood Pressure 538 514 311
4.Secondary Outcome
Title Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments
Hide Description Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: mm Hg
-16.95  (13.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.95
Confidence Interval 95%
-17.62 to -16.27
Parameter Dispersion
Type: Standard Deviation
Value: 13.34
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments
Hide Description Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: mm Hg
-9.84  (8.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.84
Confidence Interval 95%
-10.29 to -9.39
Parameter Dispersion
Type: Standard Deviation
Value: 8.39
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Change in Waist Circumference Between Baseline and 52 Week Assessments
Hide Description Absolute change in Waist Circumference between baseline and 52 week assessments
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: cm
-1.28  (5.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Parameter Dispersion
Type: Standard Deviation
Value: 5.4
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Change in Body Mass Index Between Baseline and 52 Week Assessments
Hide Description Absolute change in Body Mass Index Baseline and 52 week assessments
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: Kg/m2
-7.3  (5.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.3
Parameter Dispersion
Type: Standard Deviation
Value: 5.20
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments
Hide Description Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks – LDL-C Baseline) / (LDL-C Baseline)].
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: Percent Change
-1.49  (32.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.5
Parameter Dispersion
Type: Standard Deviation
Value: 32.1
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments
Hide Description Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks – HDL-C 52 Baseline) / (HDL-C Baseline)].
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.21  (17.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Parameter Dispersion
Type: Standard Deviation
Value: 18.0
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Percent Change in Triglycerides Between Baseline and 52 Week Assessments
Hide Description Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks – Triglycerides Baseline) / (Triglycerides Baseline)].
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Median (Standard Deviation)
Unit of Measure: Percent Change
1.09  (43.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Parameter Dispersion
Type: Standard Deviation
Value: 43.5
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments
Hide Description Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks – Total Cholesterol Baseline) / (Total Cholesterol Baseline)].
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: Percent Change
-2.98  (16.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Parameter Dispersion
Type: Standard Deviation
Value: 17.0
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Absolute Change in Uric Acid Between Baseline and 52 Week Assessments
Hide Description Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks – Uric Acid Baseline.
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: mmol/L
-19.17  (63.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.2
Parameter Dispersion
Type: Standard Deviation
Value: 63.8
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments
Hide Description Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks – C Reactive Protein Baseline.
Time Frame 52 Weeks - Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Losartan +/- Hydrochlorothiazide
Hide Arm/Group Description:
Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
Overall Number of Participants Analyzed 1511
Mean (Standard Deviation)
Unit of Measure: mg/L
-0.36  (8.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan +/- Hydrochlorothiazide
Comments Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.613
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Parameter Dispersion
Type: Standard Deviation
Value: 8.7
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall ITT
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Overall ITT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall ITT
Affected / at Risk (%)
Total   35/1714 (2.04%) 
Cardiac disorders   
Acute coronary syndrome  1  1/1714 (0.06%) 
Atrial flutter  2  1/1714 (0.06%) 
Cardiomyopathy  1  1/1714 (0.06%) 
Infarction  1  1/1714 (0.06%) 
Single Vessel Disease  1  1/1714 (0.06%) 
Gastrointestinal disorders   
Gastric Ulcer  1  1/1714 (0.06%) 
Nausea  1  1/1714 (0.06%) 
Vomiting  1  1/1714 (0.06%) 
Ulcer Bleeding Gastric  1  1/1714 (0.06%) 
General disorders   
Chest Pain  1  1/1714 (0.06%) 
Death  1  2/1714 (0.12%) 
Immune system disorders   
Anaphylactic shock  1  1/1714 (0.06%) 
Anaphylaxis  1  1/1714 (0.06%) 
Infections and infestations   
Pneumonia  1  1/1714 (0.06%) 
Injury, poisoning and procedural complications   
Ankle fracture  1  1/1714 (0.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer  1  3/1714 (0.18%) 
Lymphoma grade IV  1  1/1714 (0.06%) 
Nervous system disorders   
Cerebral vascular accident  1  3/1714 (0.18%) 
Multiple sclerosis aggravated  1  1/1714 (0.06%) 
Numbness of Upper Arm  1  1/1714 (0.06%) 
Subarachnoid Hemorrhage  1  1/1714 (0.06%) 
Psychiatric disorders   
Acute depression  1  1/1714 (0.06%) 
Renal and urinary disorders   
Acute renal insufficiency  1  1/1714 (0.06%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis asthmatic  1  1/1714 (0.06%) 
Surgical and medical procedures   
Cardiac catheterization  1  1/1714 (0.06%) 
Hip Replacement  1  2/1714 (0.12%) 
Ileostomy  1  1/1714 (0.06%) 
Rotator Cuff Repair  1  1/1714 (0.06%) 
Vascular disorders   
Atherosclerotic cardiovascular disease  1  1/1714 (0.06%) 
Superficial Femoral Arterial Stenosis  1  1/1714 (0.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
2
Term from vocabulary, MedDRA 10.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Overall ITT
Affected / at Risk (%)
Total   198/1714 (11.55%) 
Infections and infestations   
Sinusitis  1  19/1714 (1.11%) 
Investigations   
Blood Glucose Increased (per investigator's clinical judgment)  1  17/1714 (0.99%) 
Metabolism and nutrition disorders   
Type 2 diabetes mellitus  1  54/1714 (3.15%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  23/1714 (1.34%) 
Nervous system disorders   
Dizziness  1  35/1714 (2.04%) 
Headache  1  21/1714 (1.23%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis  1  29/1714 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00546052     History of Changes
Other Study ID Numbers: 0954A-331
MK0954A-331
2007_030
First Submitted: October 17, 2007
First Posted: October 18, 2007
Results First Submitted: January 8, 2009
Results First Posted: June 23, 2009
Last Update Posted: May 5, 2017