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

NCT01167153 | Completed Phase 4 Results

• 1 other identifier: CVAA489ACN02
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 12 weeks

• 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.

  Baseline, 12 weeks

Secondary Outcomes (5)

• 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

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

  12 weeks

• Change From Baseline in Orthostatic SBP and DBP at 12 Weeks

  Baseline, 12 weeks

• Change From Baseline in Sitting Pulse at 12 Weeks

  Baseline, 12 weeks

• Change From Baseline in Orthostatic Pulse at 12 Weeks

  Baseline, 12 weeks

Study Arms (2)

Valsartan/amlodipine

EXPERIMENTAL

Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.

Drug: Valsartan/Amlodipine

Nifedipine

ACTIVE COMPARATOR

Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.

Drug: Nifedipine

Interventions

Valsartan/Amlodipine DRUG

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

Also known as: Exforge®

Valsartan/amlodipine

Nifedipine DRUG

Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg

Also known as: Adalat

Nifedipine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

Beijing, China

Location

Related Publications (2)

• Xu SK, Zeng WF, Li Y, Chen LL, Xie JH, Wang JG. Effects of the valsartan/amlodipine combination and nifedipine gastrointestinal therapeutic system monotherapy on brachial pulse pressure and radial augmentation index in hypertensive patients. Blood Press Monit. 2021 Aug 1;26(4):251-256. doi: 10.1097/MBP.0000000000000527.

  PMID: 33734121 DERIVED

• Wang JG, Zeng WF, He YS, Chen LL, Wei M, Li ZP, Zhang BW, Li Y; EXAM Investigators. Valsartan/amlodipine compared to nifedipine GITS in patients with hypertension inadequately controlled by monotherapy. Adv Ther. 2013 Aug;30(8):771-83. doi: 10.1007/s12325-013-0048-x. Epub 2013 Aug 21.

  PMID: 23963546 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug Combination; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Valsartan; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amlodipine; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 1, 2012
• Results First Posted: June 1, 2012

Record last verified: 2012-05

Locations

CN (1)