Safety and Efficacy of Daily Use of Micamlo® Combination... | NCT01353274

Status Module

Label	Type	Description	Intervention Names
Patients with hypertension			Drug: Micamlo

Name	Type	Description	Arm Group Labels	Other Names
Micamlo	Drug	Telmisartan plus Amlodipine T40/A5	Patients with hypertension

Measure	Description	Time Frame
Incidence of Drug-related Adverse Events	Number of patients with drug-related adverse events	12 months

Measure	Description	Time Frame
Change From Baseline in Systolic Blood Pressure (SBP)	Change from baseline in SBP after 1, 2, 3, 6, 12 months	after 1, 2, 3, 6, 12 months
Change From Baseline in Diastolic Blood Pressure (DBP)

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site 199		Akaiwa			Japan
Boehringer Ingelheim Investigational Site 83

Results Section

Participant Flow Module

ID	Title	Description
FG000	Patients With Hypertension	Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Incidence of Drug-related Adverse Events

Number of patients with drug-related adverse events

Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact

Posted

Number

participants

12 months

ID	Title	Description
OG000	Patients With Hypertension	Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Units	Counts
Participants	OG0001109

Title

Denominators

Categories

Title	Measurements
	OG00060

Secondary

Change From Baseline in Systolic Blood Pressure (SBP)

Change from baseline in SBP after 1, 2, 3, 6, 12 months

Efficacy set: all patients in the safety set who were labelled by T40/A5 mg Fixed Dose Combination (FDC) and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.

Posted

Mean

Standard Deviation

mmHg

after 1, 2, 3, 6, 12 months

ID	Title	Description
OG000	Patients With Hypertension	Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Diastolic Blood Pressure (DBP)

Change from baseline in DBP after 1, 2, 3, 6, 12 months

Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.

Posted

Mean

Standard Deviation

mmHg

after 1, 2, 3, 6, 12 months

ID	Title	Description
OG000	Patients With Hypertension	Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Who Achieved the Target BP

Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months

Posted

Number

Percentage of patients (target BP)

after 1, 2, 3, 6, 12 months

ID	Title	Description
OG000	Patients With Hypertension	Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Who Normalised Their BP

Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months

Posted

Number

Percentage of patients (normalised BP)

after 1, 2, 3, 6, 12 months

ID	Title	Description
OG000	Patients With Hypertension	Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MEDDRA 16.1	Systematic Assessment	EG0002 affected1,109 at risk
Cardiac failure	Cardiac disorders	MEDDRA 16.1	Systematic Assessment	EG0002 affected1,109 at risk
Intestinal obstruction	Gastrointestinal disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Upper gastrointestinal haemorrage	Gastrointestinal disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Anaphylactic shock	Immune system disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Pneumonia	Infections and infestations	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Foot fracture	Injury, poisoning and procedural complications	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Road traffic accident	Injury, poisoning and procedural complications	MEDDRA 16.1	Systematic Assessment	EG0002 affected1,109 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Cerebral haemorrhage	Nervous system disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Dementia	Nervous system disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Subarachnoid haemorrhage	Nervous system disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Transient ischaemic attack	Nervous system disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Nephrosclerosis	Renal and urinary disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Renal failure	Renal and urinary disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Renal failure chronic	Renal and urinary disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Renal impairment	Renal and urinary disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk
Aortic dissection	Vascular disorders	MEDDRA 16.1	Systematic Assessment	EG0001 affected1,109 at risk

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases