Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg (EXPLOR)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00687973
First received: March 20, 2008
Last updated: March 8, 2011
Last verified: March 2011
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Purpose
Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Valsartan/amlodipine 80/5 mg tablets Drug: Amlodipine 5 mg capsules Drug: Amlodipine 10 mg capsules Drug: Atenolol 50 mg tablets Drug: Atenolol 100 mg tablets |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
- Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline of Augmentation Index (Aix) at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.
- Change From Baseline of Aix at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline of Aix Corrected to Heart Rate at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]The heart rate correction was computed by a multivariate model analysis
- Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.
- Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline of SBP/DBP at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline of Pulse Pressure at Week 24 (Office BP) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 393 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Valsartan/amlodipine 160/10 mg
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
|
Drug: Valsartan/amlodipine 80/5 mg tablets |
|
Active Comparator: Atenolol/amlodipine 100/10 mg
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
|
Drug: Amlodipine 5 mg capsules Drug: Amlodipine 10 mg capsules Drug: Atenolol 50 mg tablets Drug: Atenolol 100 mg tablets |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients 18 years of age or older
- Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
- Written informed consent to participate in the study prior to any study procedures
Exclusion Criteria:
- Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
- Evidence of a secondary form of hypertension
- Type 1 diabetes mellitus
- History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
Contacts and Locations More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00687973 History of Changes |
| Other Study ID Numbers: | CVAA489AFR02 |
| Study First Received: | March 20, 2008 |
| Results First Received: | December 22, 2010 |
| Last Updated: | March 8, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Ministry of Health |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Atenolol Valsartan Amlodipine, valsartan drug combination Amlodipine Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013