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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan/Amlodipine; Drug: Nifedipine

• Registration Number: NCT01167153
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-04-19
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-31
• Last Update Submitted: 2012-05-31
• Results First Posted: 2012-06-01
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 564

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 exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.
• Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Other protocol-defined inclusion/exclusion criteria applied.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan/amlodipine	Valsartan/Amlodipine	Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine	Nifedipine	Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇳 Beijing, China