A 6-week, multicenter, randomized, double-blind, parallel-group study to evaluate the combination of valsartan/HCTZ (160/12.5 mg with forced titration to a maximum dose of 320/25 mg) compared to valsartan monotherapy (160 mg with forced titration to 320 mg) as initial therapy in patients with severe hypertensio

• Conditions: Severe hypertension (MSDBP = 110 mmHg and < 120 mmHg).

• Registration Number: EUCTR2005-003376-37-ES
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-10
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

1. Male or female patients, 18 to 80 years of age (inclusive). Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed.
2. Diagnosis of severe hypertension (MSDBP = 110 mmHg and < 120 mmHg). Patients must also have a MSSBP = 140 mmHg and < 200 mmHg.
3. Written informed consent to participate in the study prior to any study procedures.
4. Ability to communicate and comply with all study requirements.

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. Inability to discontinue all prior antihypertensive medications and/or the inability to completely taper off of medications per the manufacturer's recommendations safely for a period of 3 to 28 days as required by the protocol.
2. Refractory hypertension. Defined as patients on two or more antihypertensives and their MSSBP = 180 mmHg and/or MSDBP = 110 mmHg at Visit 1.
3. Known moderate or malignant retinopathy. Defined as: moderate (retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic disk).
4. History of hypertensive encephalopathy or cerebrovascular accident any time prior to Visit 1.
5. Transient ischemic attack, myocardial infarction, all types of revascularization procedures at any time prior to Visit 1.
6. Heart failure of any kind.
7. Second or third degree heart block with or without a pacemaker.
8. Angina pectoris of any type.
9. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
10. Clinically significant valvular heart disease.
11. 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 disease, pheochromocytoma, polycystic kidney disease.
12. Diabetes with poor glucose control as defined by fasting glycosylated hemoglobin (HbA1c) > 7% at Visit 1.
13. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1.
14. Known or suspected contraindications, including a history of allergy to angiotensin receptor blockers or thiazide diuretics.
15. Any surgical or medical conditions which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active or active inflammatory bowel syndrome within 12 months prior to Visit 1, currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator.
16. Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury within 1 year of Visit 1.
17. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values > 2 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
18. Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 mg/dL (men) and > 1.3 mg/dL (women), a history of dialysis, or a history of nephrotic syndrome.
19. History of clinically significant allergies including asthma, multiple drug allergies.
20. History of systemic lupus erythematosus.
21. History of gouty arthritis.
22. Serum sodium and/or serum potassium less than 132 mEq/L and 3.2 mEq/L, respectively at Visit 2.
23. Volume depletion.
24. Currently taking concomitant medication(s) listed in Section 6.6.5.
25. Any chronic inflammatory condition needing chronic anti-inflammatory therapy.
26. History of malignancy including leukemia and lymphoma (but not basal skin cancer) w

Study & Design

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