Clinical trial NCT01001572: Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Official title: A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Blood pressure
hypertension
Exforge
valsartan/amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.


Eligibility criteria: Inclusion Criteria:

* Patients must give written informed consent
* Male or female ages 18 or older and less than 86 years
* Diagnosed as having essential diastolic hypertension, as follows:

  * Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and \< 100 mmHg
  * At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP \>=90 mmHg and \<110 mmHg

Exclusion Criteria:

* Severe hypertension
* Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
* Malignant hypertension
* Administration of any agent indicated for the treatment of hypertension after Visit 1
* Known moderate or malignant retinopathy.
* Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
* History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
* History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
* Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint
timeFrame: Baseline and Week 8
measure: Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint
timeFrame: Baseline and Week 8
measure: Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint
timeFrame: Week 8
measure: Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint
timeFrame: Week 8
Other outcomes:
Locations:
facility: Investigative site in Romainia
facility: Novartis Investigative Site
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: