BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiaz... | NCT00546754

Label	Type	Description	Intervention Names
1	Experimental	Drug Arm	Drug: losartan potassium (+) hydrochlorothiazide
2	Active Comparator	active comparator	Drug: Comparator: Valsartan (+) Hydrochlorothiazide

Name	Type	Description	Arm Group Labels	Other Names
losartan potassium (+) hydrochlorothiazide	Drug	losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide

Measure	Description	Time Frame
Change in Systolic Blood Pressure From Baseline to Week 12		Baseline and Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12		Baseline and Week 12

Measure	Description	Time Frame
Change in Systolic Blood Pressure From Baseline to Week 6		Baseline and Week 6
Change in Diastolic Blood Pressure From Baseline to Week 6		Baseline and Week 6

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An Adult Patient 18 to 75 Years Of Age
Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
Either systolic or diastolic blood pressure > 140/90 mm Hg up to 180/110 mm Hg (inclusive)
Either systolic or diastolic blood pressure > 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients
Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:
- Surgically sterilized female
- Postmenopausal female > 45 years of age with > 2 years since her last menses
- Non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy [either 2 barrier methods or a barrier method plus a hormonal method]; or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with Visit 1 and for 14 days after the last dose of study medication
- Patient judged to be in otherwise good, stable health on the basis of medical history and physical examination

Exclusion Criteria:

Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
Patient taking allopurinol
Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartate transaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months
Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents
Patient with symptomatic heart failure (classes 3 and 4)
Patient with a history of stroke within the last 6 months
Patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina
Patient having participated in an investigational drug program in the last 30 days (prior to Visit 1)
Unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion
Patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

ID	Title	Description
FG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
FG001	Valsartan 80 mg/HCTZ 12.5 mg

ID	Title	Description
BG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure. 416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])
BG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure. 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000416 BG001373 BG002789

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

Secondary

Change in Systolic Blood Pressure From Baseline to Week 6

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

mm Hg

Baseline and Week 6

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000392 OG001344

Title

Denominators

Categories

Title	Measurements
	OG000-16.7± 14.70 OG001-18.2± 13.84

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA		0.153							95							Superiority or Other (legacy)

Secondary

Change in Diastolic Blood Pressure From Baseline to Week 6

Posted

Mean

Standard Deviation

mm Hg

Baseline and Week 6

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Number of Patients Achieving Target Blood Pressure at Week 6

Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Number

Patients

Week 6

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Primary

Change in Systolic Blood Pressure From Baseline to Week 12

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

mm Hg

Baseline and Week 12

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Number of Patients Achieving Target Blood Pressure at Week 12

Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Number

Patients

12 Weeks

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Time to Achieve Target Blood Pressure

Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

Days

12 weeks

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Change in Uric Acid From Baseline to Week 6

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

umol/L

Baseline and Week 6

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Primary

Change in Diastolic Blood Pressure From Baseline to Week 12

Posted

Mean

Standard Deviation

mm Hg

Baseline and Week 12

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Change in Uric Acid From Baseline to Week 12

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

umol/L

Baseline and Week 12

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

mg/L

Baseline and Week 6

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 255 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

umol/L

Baseline and Week 12

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 300 and 273 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

IU/L

Baseline and Week 6

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Secondary

Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12

416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 254 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Posted

Mean

Standard Deviation

IU/L

Baseline and Week 12

ID	Title	Description
OG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
OG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Visual disturbance	Eye disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0003 events3 affected425 at risk EG0011 events1 affected383 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0003 events3 affected425 at risk EG0010 events0 affected383 at risk
Dyspepsia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected383 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected383 at risk
Asthenia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected383 at risk
Chest discomfort	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Chest pain	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Fatigue	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Feeling abnormal	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Inflammation	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Malaise	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Pain	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Slugishness	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected383 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected383 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Helicobacter infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Influenza	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Mastitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Rhinitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected383 at risk
Back sprain	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Incorrect does administered	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Wrong technique in drug usage process	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected383 at risk
Blood creatinine increased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected383 at risk
Blood glucose increased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Blood potassium abnormal	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Blood potassium increased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0003 events3 affected425 at risk EG0011 events1 affected383 at risk
Blood pressure decreased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
C-Reactive protein increased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0007 events7 affected425 at risk EG0013 events3 affected383 at risk
Cardiac murmur	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Heart rate increased	Investigations	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected383 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 events2 affected425 at risk EG0011 events1 affected383 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected383 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Dizziness	Nervous system disorders	MedDRA 12.0		EG0003 events3 affected425 at risk EG0014 events4 affected383 at risk
Headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0004 events4 affected425 at risk EG0014 events4 affected383 at risk
Tremor	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected383 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Mood swings	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Renal impairment	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected383 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 12.0		EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Hot flush	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D049971	Thiazides
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.			11	425	56	425
EG001	Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.			5	383	57	383

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Critical illness polyneuropathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0012 events2 affected383 at risk
Completed suicide	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Renal failure	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected383 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected383 at risk

ID	Term
C505809	hydrochlorothiazide, losartan drug combination
D006852	Hydrochlorothiazide

ID	Type	Description	Link
MK0954A-333
2007_031