An 8 week double-blind, randomized, multicenter, parallel group study to evaluate the efficacy and safety of orally administered valsartan/amlodipine combination based therapy versus amlodipine monotherapy in patients with stage II hypertension.

Phase 1

• Conditions: Hypertension

• Registration Number: EUCTR2006-000850-33-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-18
• Study Completion: 2007-04-10
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female outpatients = 18 years of age.
2.Patients with stage II hypertension defined as MSSBP = 160 mmHg and MSSBP < 200 mmHg, measured using a validated automated oscillometric device at Visit 2 at the study site.
3.Treatment naïve patients should have MSSBP = 160 mmHg and < 200 mmHg at Visit 2.
4.Eligible patients must sign and receive a copy of written informed consent after the purpose and nature of the investigation has been clearly explained, and comprehension noted.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known or suspected contraindications, including history of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics or to drugs with similar chemical structures.
2.Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 21 days prior to Visit 2, as required by the protocol.
3.Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that require tapering down.
4.MSSBP = 200 mmHg and/or MSDBP > 120 mmHg at any time during the study.
5.Patients with controlled hypertension (MSSBP < 140 mmHg) taking more than 3 antihypertensive medications at Visit 1.
6.Patients with uncontrolled hypertension (MSSBP = 140 mmHg and < 180 mmHg) taking more than two antihypertensive medications at Visit 1.
7.Patients with uncontrolled hypertension (MSSBP = 180 mmHg) taking more than one antihypertensive medication at Visit 1.
8.History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), myocardial infarction or unstable angina pectoris.
9.Malignant hypertension.
10.Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, polycystic kidney disease, or pheochromocytoma.
11.Known moderate or malignant retinopathy. Moderate is defined as retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof. Malignant is defined as signs of moderate plus swelling of the optic disk.
12.Patients with Type 1 diabetes mellitus
13.Patients with Type 2 diabetes mellitus who are not well controlled based on the investigator’s clinical judgment. Patients currently being treated for diabetes mellitus must have satisfactory metabolic control. Type 2 diabetic patients taking oral antidiabetic medication must be on a stable dose for at least 4 weeks prior to Visit 1.
14.History of heart failure Grade II - IV according to the NYHA classification.
15.Second or third degree heart block with or without a pacemaker.
16.Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia.
17.Clinically significant valvular heart disease.
18.Active gouty arthritis.
19.History of autoimmune diseases including systemic lupus erythematosus.
20.History of multiple drug allergies.
21.Evidence of hepatic disease as determined by one of the following: SGOT (AST) or SGPT (ALT) values > 2 x UNL at Visit 1, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt.
22.Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury within 12 months of Visit 1.
23.Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x UNL at visit 1, history of dialysis, or history of nephrotic syndrome.
24.Serum sodium value < 132 mmol/L at Visit 1.
25.S

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified