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Trial record 45 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00496834
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : December 15, 2010
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: losartan potassium
Drug: Comparator: carvedilol
Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)
Drug: Comparator: carvedilol (+) hydrochlorothiazide
Enrollment 201
Recruitment Details

7 centers participated in this study (7 medical centers of university).

FPE (First patient enrolled): Feb-2008, FPI (First patient in): Feb-2008, LPO (Last patient out): Sep-2009

Pre-assignment Details  
Arm/Group Title Losartan Carvedilol
Hide Arm/Group Description Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).

Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or

Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).

Period Title: Overall Study
Started 101 100
Completed 83 87
Not Completed 18 13
Reason Not Completed
Withdrawal by Subject             4             6
Contraindicated medication administered             0             1
Inclusion/exclusion criteria not met             3             2
Adverse Event             5             3
IP administration violation             2             0
Lost to Follow-up             2             0
Blood Pressure control failure             2             1
Arm/Group Title Losartan Carvedilol Total
Hide Arm/Group Description Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).

Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or

Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).

Total of all reporting groups
Overall Number of Baseline Participants 101 100 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 100 participants 201 participants
49.0  (9.3) 50.1  (10.2) 49.6  (9.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 201 participants
>= 18 to < 65 years 96 91 187
>=65 years 5 9 14
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 201 participants
Female
63
  62.4%
57
  57.0%
120
  59.7%
Male
38
  37.6%
43
  43.0%
81
  40.3%
DBP (diastolic blood pressure)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 101 participants 100 participants 201 participants
96.4  (8.8) 96.4  (8.3) 96.4  (8.5)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 101 participants 100 participants 201 participants
164.9  (7.8) 163.3  (9.2) 164.1  (8.5)
PWV (pulse wave velocity)  
Mean (Standard Deviation)
Unit of measure:  Meters/second
Number Analyzed 101 participants 100 participants 201 participants
7.6  (1.4) 7.7  (1.4) 7.6  (1.4)
Pulse  
Mean (Standard Deviation)
Unit of measure:  BPM (beats per minute)
Number Analyzed 101 participants 100 participants 201 participants
71.8  (10.0) 72.3  (10.0) 72.0  (10.0)
SBP (systolic blood pressure)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 101 participants 100 participants 201 participants
150.6  (11.0) 152.7  (12.1) 151.6  (11.6)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 101 participants 100 participants 201 participants
70.9  (10.6) 69.9  (13.2) 70.4  (12.0)
1.Primary Outcome
Title Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Hide Description Analysis was performed in the modified intention to treat (mITT) population.
Time Frame Baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique.
Arm/Group Title Losartan Carvedilol
Hide Arm/Group Description:
Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.

Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or

Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.

Overall Number of Participants Analyzed 88 94
Mean (Standard Deviation)
Unit of Measure: meters/second
0.28  (1.29) -0.12  (1.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan, Carvedilol
Comments Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94).
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority margin= -1.5m/s
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.83 to 0.01
Parameter Dispersion
Type: Standard Deviation
Value: 1.43
Estimation Comments The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.
2.Primary Outcome
Title PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Hide Description Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.
Time Frame Baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.
Arm/Group Title Losartan Carvedilol
Hide Arm/Group Description:
Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation.

Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or

Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation.

Overall Number of Participants Analyzed 54 67
Mean (Standard Deviation)
Unit of Measure: meters/second
0.16  (1.25) -0.20  (1.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan, Carvedilol
Comments Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority margin=-1.5m/s
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.86 to 0.15
Parameter Dispersion
Type: Standard Deviation
Value: 1.40
Estimation Comments The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.
3.Secondary Outcome
Title Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.
Arm/Group Title Losartan Carvedilol
Hide Arm/Group Description:
Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.

Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or

Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.

Overall Number of Participants Analyzed 88 94
Mean (Standard Deviation)
Unit of Measure: mm Hg
-15.08  (14.59) -14.81  (15.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan, Carvedilol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9032
Comments Significance level=0.05
Method t-test, 2 sided
Comments The secondary efficacy analysis was performed in the modified intention to treat population using t-test.
4.Secondary Outcome
Title Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.
Arm/Group Title Losartan Carvedilol
Hide Arm/Group Description:
Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.

Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or

Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.

Overall Number of Participants Analyzed 88 94
Mean (Standard Deviation)
Unit of Measure: mm Hg
-8.43  (9.29) -7.81  (9.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Losartan, Carvedilol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6574
Comments Significance level=0.05
Method t-test, 2 sided
Comments The secondary efficacy analysis was performed in the modified intention to treat population using t-test
Time Frame Adverse events were recorded from first administration of study drug up to 14 days after the administration of final dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan Carvedilol
Hide Arm/Group Description Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once.

Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or

Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once.

All-Cause Mortality
Losartan Carvedilol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Losartan Carvedilol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/101 (4.95%)      6/100 (6.00%)    
Cardiac disorders     
Prinzmetal angina  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Gastrointestinal disorders     
Mouth haemorrhage  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Infections and infestations     
Chronic sinusitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Injury, poisoning and procedural complications     
Overdose  1  1/101 (0.99%)  1 5/100 (5.00%)  5
Ligament sprain  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Nervous system disorders     
Myelitis transverse  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Vascular disorders     
Haematoma  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Losartan Carvedilol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/101 (34.65%)      51/100 (51.00%)    
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Cardiac disorders     
Atrioventricular block first degree  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Bradycardia  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Palpitations  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Ear and labyrinth disorders     
Tinnitus  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Eye disorders     
Conjunctivitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Eye pain  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Gastrointestinal disorders     
Dyspepsia  1  3/101 (2.97%)  3 3/100 (3.00%)  3
Nausea  1  0/101 (0.00%)  0 3/100 (3.00%)  3
Duodenal ulcer  1  0/101 (0.00%)  0 2/100 (2.00%)  2
Abdominal discomfort  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Constipation  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Diarrhoea  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Gastric ulcer  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Gastritis  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Haemorrhoids  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Melaena  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Mouth ulceration  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Periodontitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Reflux gastritis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Reflux oesophagitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Toothache  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Vomiting  1  0/101 (0.00%)  0 1/100 (1.00%)  1
General disorders     
Chest pain  1  2/101 (1.98%)  2 3/100 (3.00%)  3
Chest discomfort  1  2/101 (1.98%)  2 2/100 (2.00%)  2
Fatigue  1  0/101 (0.00%)  0 2/100 (2.00%)  2
Face oedema  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Oedema peripheral  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Infections and infestations     
Nasopharyngitis  1  4/101 (3.96%)  4 7/100 (7.00%)  10
Acute sinusitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Bronchiolitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Herpes zoster  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Pharyngitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Pharyngotonsillitis  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Upper respiratory tract infection  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Injury, poisoning and procedural complications     
Joint sprain  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Metabolism and nutrition disorders     
Hyperlipidaemia  1  1/101 (0.99%)  1 2/100 (2.00%)  2
Anorexia  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/101 (0.99%)  1 2/100 (2.00%)  2
Tendonitis  1  1/101 (0.99%)  1 1/100 (1.00%)  1
Musculoskeletal stiffness  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Myofascial pain syndrome  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Pain in extremity  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign colonic neoplasm  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Uterine leiomyoma  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Nervous system disorders     
Headache  1  8/101 (7.92%)  8 9/100 (9.00%)  12
Dizziness  1  5/101 (4.95%)  5 3/100 (3.00%)  3
Dizziness postural  1  0/101 (0.00%)  0 2/100 (2.00%)  2
Cerebral infarction  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Hypoaesthesia  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Migraine  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Psychiatric disorders     
Insomnia  1  1/101 (0.99%)  1 1/100 (1.00%)  1
Renal and urinary disorders     
Pollakiuria  1  2/101 (1.98%)  2 1/100 (1.00%)  1
Haematuria  1  0/101 (0.00%)  0 2/100 (2.00%)  4
Dysuria  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Reproductive system and breast disorders     
Erectile dysfunction  1  0/101 (0.00%)  0 3/100 (3.00%)  3
Menopausal symptoms  1  1/101 (0.99%)  1 1/100 (1.00%)  1
Benign prostatic hyperplasia  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/101 (0.99%)  1 1/100 (1.00%)  2
Cough  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Nasal congestion  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Productive cough  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Rhinorrhoea  1  1/101 (0.99%)  1 0/100 (0.00%)  0
Upper respiratory tract inflammation  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Skin and subcutaneous tissue disorders     
Pruritus allergic  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Rash maculo-papular  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Urticaria  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Surgical and medical procedures     
Tooth extraction  1  0/101 (0.00%)  0 1/100 (1.00%)  1
Vascular disorders     
Ischaemia  1  2/101 (1.98%)  2 0/100 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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: NCT00496834     History of Changes
Obsolete Identifiers: NCT01001416
Other Study ID Numbers: 0954-330
2007_015
First Submitted: July 3, 2007
First Posted: July 4, 2007
Results First Submitted: August 26, 2010
Results First Posted: December 15, 2010
Last Update Posted: May 5, 2017