Phase 3
N=932
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01001572 ↗Enrolled (actual)
932
Serious AEs
0.2%
Results posted
May 2011
Primary outcome: Primary: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint — -10.3; -6.6 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Valsartan/amlodipine 160/5 mg (Drug); Valsartan 160 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint |
-10.3; -6.6 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint |
-14.9; -7.0 | — |
| SECONDARY Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint |
70.1; 52.6 | — |
| SECONDARY Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint |
65.9; 50.8 | — |
| SECONDARY Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint |
61.3; 39.3 | — |
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 =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
Data sourced from ClinicalTrials.gov (NCT01001572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.