Trial Outcomes & Findings for Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients (NCT NCT01167153)

NCT ID: NCT01167153

Last Updated: 2012-06-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 564 participants
• Primary outcome timeframe: Baseline, 12 weeks
• Results posted on: 2012-06-01

Participant Flow

Participant milestones

Measure	Valsartan/Amlodipine Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Study STARTED	282	282
Overall Study Intention to Treat (ITT)	272	268
Overall Study COMPLETED	264	249
Overall Study NOT COMPLETED	18	33

Reasons for withdrawal

Measure	Valsartan/Amlodipine Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Study Non-effective therapy	1	4
Overall Study AE including clinical laboratory AE	2	8
Overall Study Hypotension	1	0
Overall Study Lost to Follow-up	7	9
Overall Study Non-compliance to concomitant medication	0	2
Overall Study Investigator initiation withdrawal,Other	1	1
Overall Study Withdrawal consent	1	1
Overall Study Subject initiation withdrawal, Other	5	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Valsartan/Amlodipine n=272 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=268 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Total n=540 Participants Total of all reporting groups
Age Continuous	53.8 years STANDARD_DEVIATION 8.59 • n=5 Participants	53.1 years STANDARD_DEVIATION 8.72 • n=7 Participants	53.5 years STANDARD_DEVIATION 8.63 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	135 Participants n=7 Participants	270 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	133 Participants n=7 Participants	270 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Valsartan/Amlodipine n=267 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=265 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
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	-10.6 mm Hg Standard Deviation 12.02

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Valsartan/Amlodipine n=267 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=265 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
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	-4.8 mm Hg Standard Deviation 8.89

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Valsartan/Amlodipine n=267 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=265 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 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) Achieving Effective SBP Control	82.40 Percentage of participants	63.40 Percentage of participants
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	76.98 Percentage of participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Valsartan/Amlodipine n=267 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=265 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks	79.03 Percentage of participants	57.36 Percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Valsartan/Amlodipine n=266 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=265 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Change From Baseline in Orthostatic SBP and DBP at 12 Weeks Orthostatic diastolic blood pressure	-7.2 mm Hg Standard Deviation 9.43 • Interval -8.2172 to -6.2177	-3.3 mm Hg Standard Deviation 9.58 • Interval -4.2475 to -2.2442
Change From Baseline in Orthostatic SBP and DBP at 12 Weeks Orthostatic systolic blood pressure	-13.3 mm Hg Standard Deviation 13.86 • Interval -14.3985 to -11.4312	-8.6 mm Hg Standard Deviation 13.98 • Interval -10.4851 to -7.5122

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Valsartan/Amlodipine n=267 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=264 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Change From Baseline in Sitting Pulse at 12 Weeks	-1.1 beats/min Standard Deviation 8.49	0.0 beats/min Standard Deviation 8.22

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Valsartan/Amlodipine n=266 Participants Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=264 Participants Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Change From Baseline in Orthostatic Pulse at 12 Weeks	-0.6 beats/min Standard Deviation 8.93	0.4 beats/min Standard Deviation 8.48

Adverse Events

Valsartan/Amlodipine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Nifedipine

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Valsartan/Amlodipine n=282 participants at risk Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=282 participants at risk Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Cardiac disorders Unstable Blood Pressure	0.00% 0/282 Safety analysis population: all randomised subjects who administrated at least one dose of investigational drug.	0.35% 1/282 Safety analysis population: all randomised subjects who administrated at least one dose of investigational drug.

Other adverse events

Measure	Valsartan/Amlodipine n=282 participants at risk Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.	Nifedipine n=282 participants at risk Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nervous system disorders Dizzy	3.9% 11/282 Safety analysis population: all randomised subjects who administrated at least one dose of investigational drug.	5.3% 15/282 Safety analysis population: all randomised subjects who administrated at least one dose of investigational drug.
Nervous system disorders Headache	2.1% 6/282 Safety analysis population: all randomised subjects who administrated at least one dose of investigational drug.	7.1% 20/282 Safety analysis population: all randomised subjects who administrated at least one dose of investigational drug.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER