Telmisartan Fixed Dose Combination vs Amlodipine in Hyper... | NCT00877929

ID	Type	Description	Link
2008-000874-19	EudraCT Number	EudraCT

Status Module

Label	Type	Description	Intervention Names
Telmisartan 80 / Amlodipine 10	Experimental	Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination	Drug: Telmisartan 80 Drug: Amlodipine 10
Amlodipine 10	Active Comparator	Amlodipine 5 for two weeks, then forced titration to Amlodipine 10	Drug: Amlodipine 10

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan 80	Drug	Telmisartan 80 mg	Telmisartan 80 / Amlodipine 10

Measure	Description	Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8	Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.	Baseline, week 8

Measure	Description	Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6	Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.	Baseline, week 6
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure >150 mmHg at Visit 3 (Randomisation visit)
Diagnosis of Type 2 diabetes mellitus
=18 years of age at the date of signing the informed consent
Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Ability to provide written informed consent

Exclusion criteria:

Pre-menopausal women (last menstruation <=1 year prior to start of run-in period) who:
1. are not surgically sterile; and/or
2. are nursing or pregnant, or
3. are of child-bearing potential and are NOT practicing acceptable means of birth control or do NOT plan to continue practising an acceptable method throughout the study.
The only acceptable methods of birth control are:
- Intrauterine device (IUD);
- Oral contraceptives (started at least three months prior to start of run-in period)
- Implantable or injectable contraceptives and
- Estrogen patch
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Known or suspected secondary hypertension (e.g., renal artery stenosis, phaeochromocytoma)
Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods
Patients with Type 1 diabetes mellitus
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 µmol /L) or known creatinine clearance <30 mL/min or clinical markers of severe renal impairment
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
Clinically relevant hypokalaemia or hyperkalaemia
Uncorrected sodium or volume depletion
Primary aldosteronism
Hereditary fructose intolerance
Biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency
Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3)
Contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months prior to start of run-in period)
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C >10%
Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists
History of drug or alcohol dependency within six months prior to signing the informed consent form
Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
Any investigational drug therapy within one month of signing the informed consent
Known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)
History of non-compliance or inability to comply with prescribed medications or protocol procedures
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1235.21.901 Boehringer Ingelheim Investigational Site		Long Beach	California		United States
1235.21.907 Boehringer Ingelheim Investigational Site

ID	Title	Description
FG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
FG001	Amlodipine 10 mg

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00060.5± 10.4 BG00160.5± 9.7 BG00260.5± 10.1

Age, Customized

Number

participants

Title

Denominators

Categories

< 65 years

Title	Measurements
	BG000214 BG001235 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000172 BG001169 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian/Alaska Native

Title	Measurements
	BG0007 BG0015 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Spain

Title	Measurements
	BG00019 BG00118 BG002

Race class

Number

participants

Title

Denominators

Categories

Non-black

Title	Measurements
	BG000309 BG001313 BG002

Height

Mean

Standard Deviation

centimeter

Title

Denominators

Categories

Title	Measurements
	BG000167.1± 10.3 BG001167.6± 10.9 BG002

Weight

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00090.2± 20.9 BG00189.5± 19.4 BG002

Body Mass Index

Mean

Standard Deviation

kilogram / square meter

Title

Denominators

Categories

Title	Measurements
	BG00032.1± 6.0 BG00131.8± 6.1 BG002

Body Mass Index Class

Number

participants

Title

Denominators

Categories

< 25 kg/square meter

Title	Measurements
	BG00032 BG00131 BG002

Smoking history

Number

participants

Title

Denominators

Categories

Never smoked

Title	Measurements
	BG000221 BG001222 BG002

Alcohol history

Number

participants

Title

Denominators

Categories

Non drinker

Title	Measurements
	BG000227 BG001218 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

Treated Set includes all randomized participants who took at least one dose of treatment

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000320 OG001311

Title

Denominators

Categories

Title	Measurements
	OG000-29.0± 0.66 OG001-22.9± 0.67

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		ANCOVA	Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.	0.0001		Mean Difference (Final Values)	-6.1				95	-7.9	-4.2				No	Superiority or Other

Secondary

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg
OG001	Amlodipine 5 mg

Units	Counts
Participants	OG000333

Secondary

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1

Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg
OG001	Amlodipine 5 mg

Units	Counts
Participants	OG000334

Secondary

Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

Treated set using last observation carried forward (LOCF)

Posted

Number

participants

Baseline, week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week

Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week

Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Systolic Blood Pressure (SBP) Control 140 at Eight Weeks

Mean seated SBP < 140 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 140 at Six Weeks

Mean seated SBP < 140 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 140 at Four Weeks

Mean seated SBP < 140 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 140 at Two Weeks

Mean seated SBP < 140 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 140 at One Week

Mean seated SBP < 140 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 130 at Eight Weeks

Mean seated SBP < 130 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 130 at Six Weeks

Mean seated SBP < 130 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 130 at Four Weeks

Mean seated SBP < 130 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 130 at Two Weeks

Mean seated SBP < 130 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Control 130 at One Week

Mean seated SBP < 130 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 140 at Eight Weeks

SBP < 140 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 140 at Six Weeks

SBP <140 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 140 at Four Weeks

SBP <140 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 140 at Two Weeks

SBP <140 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 140 at One Week

SBP <140 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 130 at Eight Weeks

SBP <130 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 130 at Six Weeks

SBP <130 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 130 at Four Weeks

SBP <130 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 130 at Two Weeks

SBP <130 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

SBP Response 130 at One Week

SBP <130 mmHg or a reduction >=10 mmHg

Treated set using LOCF

Posted

Number

participants

Baseline, week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

DBP Response at Eight Weeks

Mean seated DBP<80 mmHg or a reduction of <=10 mmHg

Treated set

Posted

Number

participants

Week 8

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

DBP Response at Six Weeks

Mean seated DBP<80 mmHg or a reduction of <=10 mmHg

Treated set

Posted

Number

participants

week 6

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

DBP Response at Week Four

Mean seated DBP <80 mmHg or a reduction of >=10 mmHg

Treated set

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

DBP Response at Week Two

Mean seated DBP <80 mmHg or a reduction of >=10 mmHg

Treated set

Posted

Number

participants

Week 2

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

DBP Response at Week One

Mean seated DBP <80 mmHg or a reduction of >=10 mmHg

Treated set

Posted

Number

participants

Week 1

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 5 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 5 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)

Change from baseline in UACR (measured in spot urine) after eight weeks of treatment

Treated set

Posted

Mean

Standard Deviation

ratio

8 weeks

ID	Title	Description
OG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
OG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Cardiac failure	Cardiac disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Myocardial infarction	Cardiac disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Ulcer	General disorders	MedDRA version 13.0	Systematic Assessment	EG0001 affected352 at risk EG0010 affected354 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA version 13.0	Systematic Assessment	EG0001 affected352 at risk EG0010 affected354 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 13.0	Systematic Assessment	EG0001 affected352 at risk EG0010 affected354 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Depression	Psychiatric disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Major depression	Psychiatric disorders	MedDRA version 13.0	Systematic Assessment	EG0000 affected352 at risk EG0011 affected354 at risk
Arteriosclerosis	Vascular disorders	MedDRA version 13.0	Systematic Assessment	EG0001 affected352 at risk EG0010 affected354 at risk

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
BG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Telmisartan 80 mg + Amlodipine 10 mg	Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.			3	352	62	352
EG001	Amlodipine 10 mg	Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.			4	354	71	354