Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of Valsartan/Amlodipine and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01167153

Acronym

EXAM

Enrollment

564

Registered

2010-07-22

Start date

2010-05-31

Completion date

2011-04-30

Last updated

2012-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Valsartan Amlodipine single pill combination, BP control, ABPM, Hypertensive patients not adequately controlled by mono antihypertensive drugs

Brief summary

The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.

Interventions

DRUGValsartan/Amlodipine

Valsartan/Amlodipine 80/5mg single pill combination (SPC)

DRUGNifedipine

Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

Exclusion criteria

* Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization. * Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin \>8.0%) * Patients had evidence of hepatic disease or renal impairment * Other

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)	Baseline, 12 weeks	The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)	Baseline, 12 weeks	The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.

Secondary

Measure	Time frame	Description
Change From Baseline in Orthostatic SBP and DBP at 12 Weeks	Baseline, 12 weeks	The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.
Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)	Baseline, 12 weeks	Effective SBP control rate was defined as proportion of subjects in whom MSSBP \< 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline. Effective DBP control rate was defined as proportion of subjects in whom MSDBP \< 90 mmHg or MSDBP reduction ≥10 mmHg from baseline.
Change From Baseline in Orthostatic Pulse at 12 Weeks	Baseline, 12 weeks	Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.
Change From Baseline in Sitting Pulse at 12 Weeks	Baseline, 12 weeks	Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.
Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks	12 weeks	Blood Pressure (BP) target was defined as mean sitting BP\<140/90 mm Hg in non-diabetic patients and\<130/80 mm Hg in diabetic patients at 12 weeks.

Countries

China

Participant flow

Participants by arm

Arm	Count
Valsartan/Amlodipine Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	272
Nifedipine Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	268
Total	540

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	AE including clinical laboratory AE	2	8
Overall Study	Hypotension	1	0
Overall Study	Investigator initiation withdrawal,Other	1	1
Overall Study	Lost to Follow-up	7	9
Overall Study	Non-compliance to concomitant medication	0	2
Overall Study	Non-effective therapy	1	4
Overall Study	Subject initiation withdrawal, Other	5	8
Overall Study	Withdrawal consent	1	1

Baseline characteristics

Characteristic	Valsartan/Amlodipine	Nifedipine	Total
Age Continuous	53.8 years STANDARD_DEVIATION 8.59	53.1 years STANDARD_DEVIATION 8.72	53.5 years STANDARD_DEVIATION 8.63
Sex: Female, Male Female	135 Participants	135 Participants	270 Participants
Sex: Female, Male Male	137 Participants	133 Participants	270 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	14 / 282	32 / 282
serious Total, serious adverse events	0 / 282	1 / 282

Outcome results

Primary

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)

The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.

Time frame: Baseline, 12 weeks

Population: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline.

Arm	Measure	Value (MEAN)	Dispersion
Valsartan/Amlodipine	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)	-8.5 mm Hg	Standard Deviation 8.52
Nifedipine	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)	-4.8 mm Hg	Standard Deviation 8.89

Primary

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)

The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.

Time frame: Baseline, 12 weeks

Population: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline.

Arm	Measure	Value (MEAN)	Dispersion
Valsartan/Amlodipine	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)	-16.8 mm Hg	Standard Deviation 11.69
Nifedipine	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)	-10.6 mm Hg	Standard Deviation 12.02

Secondary

Change From Baseline in Orthostatic Pulse at 12 Weeks

Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.

Time frame: Baseline, 12 weeks

Population: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic pulse rate after baseline.

Arm	Measure	Value (MEAN)	Dispersion
Valsartan/Amlodipine	Change From Baseline in Orthostatic Pulse at 12 Weeks	-0.6 beats/min	Standard Deviation 8.93
Nifedipine	Change From Baseline in Orthostatic Pulse at 12 Weeks	0.4 beats/min	Standard Deviation 8.48

Secondary

Change From Baseline in Orthostatic SBP and DBP at 12 Weeks

The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.

Time frame: Baseline, 12 weeks

Population: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic SBP and DBP after baseline.

Arm	Measure	Group	Value (MEAN)	Dispersion
Valsartan/Amlodipine	Change From Baseline in Orthostatic SBP and DBP at 12 Weeks	Orthostatic diastolic blood pressure	-7.2 mm Hg	Standard Deviation 9.43
Valsartan/Amlodipine	Change From Baseline in Orthostatic SBP and DBP at 12 Weeks	Orthostatic systolic blood pressure	-13.3 mm Hg	Standard Deviation 13.86
Nifedipine	Change From Baseline in Orthostatic SBP and DBP at 12 Weeks	Orthostatic diastolic blood pressure	-3.3 mm Hg	Standard Deviation 9.58
Nifedipine	Change From Baseline in Orthostatic SBP and DBP at 12 Weeks	Orthostatic systolic blood pressure	-8.6 mm Hg	Standard Deviation 13.98

Secondary

Change From Baseline in Sitting Pulse at 12 Weeks

Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.

Time frame: Baseline, 12 weeks

Population: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of sitting pulse rate after baseline.

Arm	Measure	Value (MEAN)	Dispersion
Valsartan/Amlodipine	Change From Baseline in Sitting Pulse at 12 Weeks	-1.1 beats/min	Standard Deviation 8.49
Nifedipine	Change From Baseline in Sitting Pulse at 12 Weeks	0.0 beats/min	Standard Deviation 8.22

Secondary

Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks

Blood Pressure (BP) target was defined as mean sitting BP\<140/90 mm Hg in non-diabetic patients and\<130/80 mm Hg in diabetic patients at 12 weeks.

Time frame: 12 weeks

Population: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of blood pressure control after baseline

Arm	Measure	Value (NUMBER)
Valsartan/Amlodipine	Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks	79.03 Percentage of participants
Nifedipine	Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks	57.36 Percentage of participants

Secondary

Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)

Effective SBP control rate was defined as proportion of subjects in whom MSSBP \< 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline. Effective DBP control rate was defined as proportion of subjects in whom MSDBP \< 90 mmHg or MSDBP reduction ≥10 mmHg from baseline.

Time frame: Baseline, 12 weeks

Population: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of effective BP control after baseline.

Arm	Measure	Group	Value (NUMBER)
Valsartan/Amlodipine	Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)	Achieving Effective SBP Control	82.40 Percentage of participants
Valsartan/Amlodipine	Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)	Achieving Effective DBP Control	92.88 Percentage of participants
Nifedipine	Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)	Achieving Effective SBP Control	63.40 Percentage of participants
Nifedipine	Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)	Achieving Effective DBP Control	76.98 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)

Change From Baseline in Orthostatic Pulse at 12 Weeks

Change From Baseline in Orthostatic SBP and DBP at 12 Weeks

Change From Baseline in Sitting Pulse at 12 Weeks

Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks

Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)