Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT00168779
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Forced-titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg Taken Orally for Eight Weeks in Patients With Stage 1 or Stage 2 Hypertension.
• Date of first enrolment: September 2005
• Target sample size: 1185
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00168779
• Study type: Interventional
• Study design: Intervention model: Parallel Assignment. Primary purpose: Treatment.
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Ability to provide written informed consent.

2. Age 18 years or older

3. Ability to stop current antihypertensive therapy without unacceptable risk to the
patient (investigator's discretion)

4. Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline)

Exclusion Criteria:

1. Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:

1. are not surgically sterile and/or

2. are nursing or pregnant

3. are of child-bearing potential and are NOT practicing acceptable means of birth
control, do NOT plan to continue using this method throughout the study and do
NOT agree to submit to periodic pregnancy testing during participation in studies
of > 3-months duration. Acceptable methods of birth control include oral,
implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device
(IUD).

2. Known or suspected secondary hypertension.

3. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit
prior to randomization.

4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

1. SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or

2. Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.

5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney,
post-renal transplant or with only one kidney.

6. Clinically relevant hypokalemia or hyperkalemia.

7. Uncorrected volume depletion.

8. Uncorrected sodium depletion.

9. Primary aldosteronism.

10. Hereditary fructose intolerance.

11. Biliary obstructive disorders, cholestatis or moderate to severe hepatic in
sufficiency.

12. Patients who have previously experienced symptoms characteristic of angioedema during
treatment with ACE inhibitors or angiotensin II receptor antagonists.

13. History of drug or alcohol dependency within six months prior to start of run-in
period.

14. Chronic administration of any medications known to affect blood pressure, exc



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: placebo

Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg

Drug: valsartan 160 mg / hydrochlorothiazide 25 mg

Primary Outcome(s)

Mean seated trough cuff DBP and SBP [Time Frame: after 8 week]

Secondary Outcome(s)

Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points [Time Frame: after 8 weeks]

The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements [Time Frame: after 8 week]

The percentage of patients with uncontrolled hypertension [Time Frame: after 8 weeks]

Secondary ID(s)

502.476

Source(s) of Monetary Support

Please refer to primary and secondary sponsors